Trial Outcomes & Findings for Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study) (NCT NCT00432159)
NCT ID: NCT00432159
Last Updated: 2017-10-20
Results Overview
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
24 months
Results posted on
2017-10-20
Participant Flow
First subject was enrolled on July 10, 2006. The final study subjects were enrolled on March 22, 2011 and all study sites were informed that enrollment was closed effective March 31, 2011.
Participant milestones
| Measure |
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
185
|
167
|
39
|
20
|
89
|
|
Overall Study
COMPLETED
|
163
|
137
|
35
|
15
|
79
|
|
Overall Study
NOT COMPLETED
|
22
|
30
|
4
|
5
|
10
|
Reasons for withdrawal
| Measure |
1-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Failure
|
9
|
5
|
3
|
2
|
3
|
|
Overall Study
Missing NDI and/or neuro. assessment
|
13
|
24
|
1
|
3
|
7
|
Baseline Characteristics
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Baseline characteristics by cohort
| Measure |
1-level Cervical TDR
n=185 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=167 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 7.63 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 7.74 • n=4 Participants
|
42.3 years
STANDARD_DEVIATION 7.49 • n=21 Participants
|
43.4 years
STANDARD_DEVIATION 8.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
260 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
240 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
470 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
170 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
453 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
BMI
|
28.3 kg/m^2
STANDARD_DEVIATION 4.97 • n=5 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.83 • n=7 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.97 • n=5 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 3.61 • n=4 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 5.12 • n=21 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=8 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
Outcome measures
| Measure |
1-level Cervical TDR
n=169 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=133 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=38 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=17 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=82 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Overall Success
|
137 participants who are successes
|
110 participants who are successes
|
28 participants who are successes
|
13 participants who are successes
|
65 participants who are successes
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Outcome measures
| Measure |
1-level Cervical TDR
n=161 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=127 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
NDI Success
|
139 participants who are successes
|
111 participants who are successes
|
29 participants who are successes
|
13 participants who are successes
|
67 participants who are successes
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
no new clinically significant permanent abnormalities in neurological function
Outcome measures
| Measure |
1-level Cervical TDR
n=162 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=129 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=80 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Neurological Component of Success
|
161 participants who are successes
|
127 participants who are successes
|
35 participants who are successes
|
15 participants who are successes
|
77 participants who are successes
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
no subsequent secondary surgical intervention at the index level
Outcome measures
| Measure |
1-level Cervical TDR
n=185 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=167 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Subsequent Secondary Surgery Component of Success
|
176 participants who are successes
|
160 participants who are successes
|
35 participants who are successes
|
18 participants who are successes
|
84 participants who are successes
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
no device related serious adverse events
Outcome measures
| Measure |
1-level Cervical TDR
n=185 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=167 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Device-Related SAE Component of Success
|
184 participants who are successes
|
167 participants who are successes
|
39 participants who are successes
|
20 participants who are successes
|
89 participants who are successes
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Outcome measures
| Measure |
1-level Cervical TDR
n=161 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=127 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
NDI - Change From Baseline
|
-33.4 NDI Score
Standard Deviation 17.97
|
-33.2 NDI Score
Standard Deviation 18.04
|
-32.8 NDI Score
Standard Deviation 20.62
|
-32.9 NDI Score
Standard Deviation 22.10
|
-34.3 NDI Score
Standard Deviation 21.00
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=124 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Neck Pain VAS Scores - Change From Baseline
|
-47.0 Units on a scale
Standard Error 30.43
|
-41.5 Units on a scale
Standard Error 30.57
|
-36.1 Units on a scale
Standard Error 33.15
|
-27.2 Units on a scale
Standard Error 26.14
|
-46.3 Units on a scale
Standard Error 33.60
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=123 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Maximum Arm Pain VAS - Change From Baseline
|
-52.0 Units on a scale
Standard Deviation 32.69
|
-49.5 Units on a scale
Standard Deviation 33.45
|
-42.4 Units on a scale
Standard Deviation 37.54
|
-30.9 Units on a scale
Standard Deviation 44.62
|
-44.3 Units on a scale
Standard Deviation 35.61
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=123 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Average Arm Pain VAS - Change From Baseline
|
-32.1 Units on a scale
Standard Deviation 25.62
|
-28.8 Units on a scale
Standard Deviation 20.88
|
-30.5 Units on a scale
Standard Deviation 25.90
|
-20.6 Units on a scale
Standard Deviation 26.33
|
-26.6 Units on a scale
Standard Deviation 24.70
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=123 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Maximum Shoulder Pain VAS - Change From Baseline
|
-52.1 Units on a scale
Standard Deviation 31.96
|
-47.9 Units on a scale
Standard Deviation 30.18
|
-43.0 Units on a scale
Standard Deviation 34.74
|
-21.4 Units on a scale
Standard Deviation 43.84
|
-45.9 Units on a scale
Standard Deviation 38.13
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=123 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=78 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Average Shoulder Pain VAS - Change From Baseline
|
-34.1 Units on a scale
Standard Deviation 26.45
|
-31.6 Units on a scale
Standard Deviation 22.69
|
-31.7 Units on a scale
Standard Deviation 30.36
|
-15.6 Units on a scale
Standard Deviation 24.85
|
-31.0 Units on a scale
Standard Deviation 29.12
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Outcome measures
| Measure |
1-level Cervical TDR
n=154 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=117 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=77 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Dysphagia Disability Index - Change From Baseline
|
-1.3 Units on a scale
Standard Deviation 7.91
|
0.7 Units on a scale
Standard Deviation 7.22
|
0.3 Units on a scale
Standard Deviation 10.19
|
1.2 Units on a scale
Standard Deviation 5.89
|
-0.8 Units on a scale
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Outcome measures
| Measure |
1-level Cervical TDR
n=160 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=127 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=79 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
|
14.2 Units on a scale
Standard Deviation 10.66
|
13.3 Units on a scale
Standard Deviation 10.50
|
15.2 Units on a scale
Standard Deviation 9.23
|
6.6 Units on a scale
Standard Deviation 10.18
|
15.2 Units on a scale
Standard Deviation 10.73
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Outcome measures
| Measure |
1-level Cervical TDR
n=160 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=127 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=79 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
|
9.2 Units on a scale
Standard Deviation 11.66
|
8.8 Units on a scale
Standard Deviation 12.01
|
6.3 Units on a scale
Standard Deviation 12.89
|
12.2 Units on a scale
Standard Deviation 13.65
|
6.3 Units on a scale
Standard Deviation 13.19
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Outcome measures
| Measure |
1-level Cervical TDR
n=167 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=131 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=38 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=16 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=83 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Work Status Assessment
Not Working
|
28 participants
|
18 participants
|
6 participants
|
2 participants
|
11 participants
|
|
Work Status Assessment
Full Time
|
111 participants
|
91 participants
|
21 participants
|
12 participants
|
61 participants
|
|
Work Status Assessment
Part Time
|
12 participants
|
10 participants
|
2 participants
|
2 participants
|
7 participants
|
|
Work Status Assessment
Full or Part Time
|
123 participants
|
101 participants
|
23 participants
|
14 participants
|
68 participants
|
|
Work Status Assessment
Total
|
151 participants
|
119 participants
|
29 participants
|
16 participants
|
79 participants
|
|
Work Status Assessment
Not Applicable
|
16 participants
|
12 participants
|
9 participants
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Estimated Proportion of Subjects Returning to Work
Outcome measures
| Measure |
1-level Cervical TDR
n=172 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=157 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=31 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=85 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Return to Work
|
87 % of subjects who returned to work
|
86 % of subjects who returned to work
|
84 % of subjects who returned to work
|
90 % of subjects who returned to work
|
92 % of subjects who returned to work
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Clinical Assessment of Activity
Outcome measures
| Measure |
1-level Cervical TDR
n=162 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=129 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=80 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Activity
Vigorous
|
44 participants
|
41 participants
|
7 participants
|
2 participants
|
22 participants
|
|
Activity
Light
|
39 participants
|
30 participants
|
11 participants
|
5 participants
|
21 participants
|
|
Activity
Moderate
|
79 participants
|
58 participants
|
17 participants
|
8 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Subject Satisfaction (Would you have this procedure again?)
Outcome measures
| Measure |
1-level Cervical TDR
n=185 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=167 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Subject Satisfaction
Definitely Yes
|
121 participants
|
86 participants
|
24 participants
|
8 participants
|
62 participants
|
|
Subject Satisfaction
Probably Yes
|
25 participants
|
32 participants
|
5 participants
|
4 participants
|
9 participants
|
|
Subject Satisfaction
Unsure or Too Early to Tell
|
10 participants
|
6 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Subject Satisfaction
Probably Not
|
4 participants
|
3 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Subject Satisfaction
Definitely Not
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Outcome measures
| Measure |
1-level Cervical TDR
n=147 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=117 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=35 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=15 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=66 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Global Cervical Range of Motion - Change From Baseline
|
5.4 degrees
Standard Deviation 16.14
|
-2.8 degrees
Standard Deviation 14.67
|
3.0 degrees
Standard Deviation 14.88
|
-14.4 degrees
Standard Deviation 13.21
|
2.1 degrees
Standard Deviation 15.36
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Outcome measures
| Measure |
1-level Cervical TDR
n=153 Participants
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=114 Participants
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Average Radiographic Disc Height (mm) - Change From Post-op
|
-1.0 mm
Standard Deviation 0.76
|
-1.0 mm
Standard Deviation 0.83
|
—
|
—
|
—
|
Adverse Events
1-level Cervical TDR
Serious events: 59 serious events
Other events: 158 other events
Deaths: 0 deaths
1-level ACDF With Plate
Serious events: 44 serious events
Other events: 135 other events
Deaths: 0 deaths
2-level Cervical TDR
Serious events: 14 serious events
Other events: 38 other events
Deaths: 0 deaths
2-level ACDF
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Training: 1 & 2-level Cervical TDR
Serious events: 24 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1-level Cervical TDR
n=186 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=166 participants at risk
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 participants at risk
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Angina pectoris
|
2.2%
4/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Vascular disorders
Aortic aneurysm
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Appendicitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
4/186 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
6/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Hepatobiliary disorders
Biliary colic
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Cardiac arrest
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Chest pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Complication of device removal
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Conjunctivitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Convulsion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Death
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Device migration
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Eye pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.54%
1/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Impaired healing
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.2%
6/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Local swelling
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.6%
6/166 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Obesity
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Palpitations
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Postoperative wound infection
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Psychotic disorder
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radicular pain
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Sciatica
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Spinal X-ray abnormal
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.1%
2/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Surgical failure
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Visual disturbance
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer recurrent
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Wound infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
Other adverse events
| Measure |
1-level Cervical TDR
n=186 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
1-level ACDF With Plate
n=166 participants at risk
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
2-level Cervical TDR
n=39 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
2-level ACDF
n=20 participants at risk
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
|
Training: 1 & 2-level Cervical TDR
n=89 participants at risk
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Areflexia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
6/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.4%
9/166 • Number of events 9 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
15.0%
3/20 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Asthenia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.2%
32/186 • Number of events 34 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
12.7%
21/166 • Number of events 22 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
17.9%
7/39 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
40.0%
8/20 • Number of events 9 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
22.5%
20/89 • Number of events 20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Bladder disorder
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Blood glucose increased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Bronchitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Burning sensation
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
15.0%
3/20 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.0%
5/166 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
CSF pressure increased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Localised oedema
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.8%
7/186 • Number of events 8 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.0%
5/166 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
12.8%
5/39 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.6%
5/89 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Cervical root pain
|
0.54%
1/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
8.1%
15/186 • Number of events 18 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
6.0%
10/166 • Number of events 11 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.7%
3/39 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
20.0%
4/20 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Chest discomfort
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Chest pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Clonus
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Constipation
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Depression
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Device migration
|
1.1%
2/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Diarrhoea infectious
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Discomfort
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Diverticulitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Dizziness
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Immune system disorders
Drug hypersensitivity
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Drug intolerance
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Duodenitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
12/186 • Number of events 12 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
11.4%
19/166 • Number of events 19 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
20.5%
8/39 • Number of events 8 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
6.7%
6/89 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Dysphasia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.7%
3/39 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Ear and labyrinth disorders
Ear pain
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
2.7%
5/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Feeling abnormal
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Feeling cold
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
2.7%
5/186 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Folliculitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Gait disturbance
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Gastritis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.4%
4/166 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Glaucoma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Gout
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Grip strength decreased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Haematuria
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Headache
|
7.0%
13/186 • Number of events 13 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.8%
13/166 • Number of events 14 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
12.8%
5/39 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
15.0%
3/20 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
6.7%
6/89 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Heart rate irregular
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Hepatitis C
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Herpes zoster
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Hoffmann's sign
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Vascular disorders
Hypertension
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Hypoaesthesia
|
11.8%
22/186 • Number of events 26 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
9.6%
16/166 • Number of events 19 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
30.8%
12/39 • Number of events 18 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
15.0%
3/20 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
19.1%
17/89 • Number of events 25 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Hyporeflexia
|
0.54%
1/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Vascular disorders
Hypotension
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Incision site infection
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Influenza
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Influenza like illness
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Insomnia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
6.7%
6/89 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.6%
3/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.0%
5/166 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.6%
5/89 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Local swelling
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hernia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Malignant dysphagia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
2.7%
5/186 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Migraine
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Motor dysfunction
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Multiple sclerosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
17/186 • Number of events 20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.6%
6/166 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
17.9%
7/39 • Number of events 8 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
11.2%
10/89 • Number of events 14 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.7%
5/186 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.6%
6/166 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
7/186 • Number of events 10 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.4%
4/166 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.3%
4/39 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.3%
4/39 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
29.0%
54/186 • Number of events 71 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
28.3%
47/166 • Number of events 56 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
43.6%
17/39 • Number of events 25 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
45.0%
9/20 • Number of events 9 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
31.5%
28/89 • Number of events 38 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.8%
7/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.7%
3/39 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.6%
5/89 • Number of events 5 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
5/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
4.3%
8/186 • Number of events 8 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Congenital, familial and genetic disorders
Myotonia congenita
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
35.5%
66/186 • Number of events 81 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
33.1%
55/166 • Number of events 66 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
61.5%
24/39 • Number of events 38 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
45.0%
9/20 • Number of events 11 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
43.8%
39/89 • Number of events 52 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Nerve compression
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Nerve root lesion
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Neuritis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Neurological symptom
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Nuclear magnetic resonance imaging brain abnormal
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Oedema peripheral
|
1.1%
2/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Pain
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.0%
41/186 • Number of events 50 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
26.5%
44/166 • Number of events 53 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
35.9%
14/39 • Number of events 18 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
40.0%
8/20 • Number of events 17 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
20.2%
18/89 • Number of events 29 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Paraesthesia
|
11.3%
21/186 • Number of events 24 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.8%
13/166 • Number of events 17 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
17.9%
7/39 • Number of events 13 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
11.2%
10/89 • Number of events 15 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Paresis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
7.7%
3/39 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Endocrine disorders
Pituitary cyst
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Pneumonia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Postoperative wound infection
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
4/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
10.0%
2/20 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Pyrexia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radicular pain
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radiculitis cervical
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Radiculopathy
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.4%
4/166 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Reflexes abnormal
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
4.8%
9/186 • Number of events 9 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.6%
6/166 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Sciatica
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Sensory disturbance
|
0.54%
1/186 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Sensory loss
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Sinusitis
|
2.2%
4/186 • Number of events 4 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
3.4%
3/89 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Skin graft infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spinal fusion acquired
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal haemangioma
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
3.8%
7/186 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
4.5%
4/89 • Number of events 6 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Stitch abscess
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Cardiac disorders
Tachycardia
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.8%
3/166 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Tremor
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.1%
2/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Ulnar neuritis
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.1%
1/89 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Urinary tract infection
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Vascular disorders
Venous thrombosis limb
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Viral infection
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Eye disorders
Vision blurred
|
1.1%
2/186 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Nervous system disorders
Vocal cord paresis
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
3/186 • Number of events 3 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
1.2%
2/166 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
5.0%
1/20 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
6.7%
6/89 • Number of events 7 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer recurrent
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Weight decreased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Investigations
Weight increased
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.2%
2/89 • Number of events 2 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/186 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.60%
1/166 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/39 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
|
Infections and infestations
Wound infection
|
0.54%
1/186 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/166 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
2.6%
1/39 • Number of events 1 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/20 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
0.00%
0/89 • 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place