Trial Outcomes & Findings for A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (NCT NCT00235716)
NCT ID: NCT00235716
Last Updated: 2014-07-23
Results Overview
The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
613 participants
Primary outcome timeframe
6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline
Results posted on
2014-07-23
Participant Flow
Recruitment initiated in August, 2007 and concluded in March, 2012. Enrollment took place at 14 VA medical centers.
Participant milestones
| Measure |
Vitamin E
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine (Namenda)
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
Vitamin E + Memantine
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
Matching placebo pills for vitamin E and memantine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
152
|
155
|
154
|
152
|
|
Overall Study
COMPLETED
|
90
|
88
|
89
|
90
|
|
Overall Study
NOT COMPLETED
|
62
|
67
|
65
|
62
|
Reasons for withdrawal
| Measure |
Vitamin E
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine (Namenda)
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
Vitamin E + Memantine
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
Matching placebo pills for vitamin E and memantine
|
|---|---|---|---|---|
|
Overall Study
Death
|
26
|
39
|
32
|
31
|
|
Overall Study
Withdrawal by Subject
|
23
|
19
|
17
|
18
|
|
Overall Study
Lost to Follow-up
|
12
|
7
|
14
|
10
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
3
|
Baseline Characteristics
A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Vitamin E
n=152 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine (Namenda)
n=155 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
Vitamin E + Memantine
n=154 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=152 Participants
Matching placebo pills for vitamin E and memantine
|
Total
n=613 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
78.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
78.8 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
78.3 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
79.4 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
78.8 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
594 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
547 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
529 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
155 participants
n=7 Participants
|
154 participants
n=5 Participants
|
152 participants
n=4 Participants
|
613 participants
n=21 Participants
|
|
Education
<High School Graduation
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
26 participants
n=5 Participants
|
29 participants
n=4 Participants
|
137 participants
n=21 Participants
|
|
Education
High School Graduation
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
57 participants
n=5 Participants
|
56 participants
n=4 Participants
|
207 participants
n=21 Participants
|
|
Education
Some College
|
27 participants
n=5 Participants
|
38 participants
n=7 Participants
|
37 participants
n=5 Participants
|
33 participants
n=4 Participants
|
135 participants
n=21 Participants
|
|
Education
College Graduation or Advanced Degree
|
38 participants
n=5 Participants
|
28 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
134 participants
n=21 Participants
|
|
Apolipoprotein E ε4 status
Non-carriers
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
59 participants
n=5 Participants
|
55 participants
n=4 Participants
|
209 participants
n=21 Participants
|
|
Apolipoprotein E ε4 status
One ε4 allele
|
39 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
38 participants
n=4 Participants
|
165 participants
n=21 Participants
|
|
Apolipoprotein E ε4 status
Two ε4 alleles
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Apolipoprotein E ε4 status
Not Tested
|
56 participants
n=5 Participants
|
50 participants
n=7 Participants
|
43 participants
n=5 Participants
|
49 participants
n=4 Participants
|
198 participants
n=21 Participants
|
|
Concomitant Medications Acetylcholinesterase Inhibitors (AChEI)
Donepezil
|
104 participants
n=5 Participants
|
100 participants
n=7 Participants
|
100 participants
n=5 Participants
|
96 participants
n=4 Participants
|
400 participants
n=21 Participants
|
|
Concomitant Medications Acetylcholinesterase Inhibitors (AChEI)
Galantamine
|
43 participants
n=5 Participants
|
47 participants
n=7 Participants
|
49 participants
n=5 Participants
|
55 participants
n=4 Participants
|
194 participants
n=21 Participants
|
|
Concomitant Medications Acetylcholinesterase Inhibitors (AChEI)
Rivastigmine
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Concomitant Medications Acetylcholinesterase Inhibitors (AChEI)
None
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Weeks from AChEI Initiation to Randomization
≤ 12 weeks
|
46 participants
n=5 Participants
|
36 participants
n=7 Participants
|
49 participants
n=5 Participants
|
37 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Weeks from AChEI Initiation to Randomization
> 12 weeks
|
105 participants
n=5 Participants
|
119 participants
n=7 Participants
|
104 participants
n=5 Participants
|
115 participants
n=4 Participants
|
443 participants
n=21 Participants
|
|
Weeks from AChEI Initiation to Randomization
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living Inventory
|
56.6 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
57.3 units on a scale
STANDARD_DEVIATION 14.2 • n=7 Participants
|
56.4 units on a scale
STANDARD_DEVIATION 14.0 • n=5 Participants
|
56.8 units on a scale
STANDARD_DEVIATION 13.7 • n=4 Participants
|
56.8 units on a scale
STANDARD_DEVIATION 14.2 • n=21 Participants
|
|
Mini-Mental State Examination
|
21.3 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 3.8 • n=4 Participants
|
21.0 units on a scale
STANDARD_DEVIATION 3.6 • n=21 Participants
|
|
Alzheimer's Disease Assessment Scale - Cognitive portion
|
18.5 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 7.9 • n=7 Participants
|
18.0 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 8.4 • n=4 Participants
|
18.8 units on a scale
STANDARD_DEVIATION 8.4 • n=21 Participants
|
|
Neuropsychiatric Inventory
|
12.2 units on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 13.1 • n=7 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 14.2 • n=4 Participants
|
12.5 units on a scale
STANDARD_DEVIATION 13.4 • n=21 Participants
|
|
Caregiver Activity Survey
|
7.3 hours per day
STANDARD_DEVIATION 14.3 • n=5 Participants
|
6.7 hours per day
STANDARD_DEVIATION 9.0 • n=7 Participants
|
6.6 hours per day
STANDARD_DEVIATION 10.5 • n=5 Participants
|
6.5 hours per day
STANDARD_DEVIATION 9.2 • n=4 Participants
|
6.8 hours per day
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Dependence Scale
Level 0
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Dependence Scale
Level 1
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Dependence Scale
Level 2
|
85 participants
n=5 Participants
|
91 participants
n=7 Participants
|
80 participants
n=5 Participants
|
79 participants
n=4 Participants
|
335 participants
n=21 Participants
|
|
Dependence Scale
Level 3
|
31 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
37 participants
n=4 Participants
|
134 participants
n=21 Participants
|
|
Dependence Scale
Level 4
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
8 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Dependence Scale
Level 5
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
20 participants
n=4 Participants
|
66 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baselinePopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.
Outcome measures
| Measure |
Vitamin E + Memantine
n=139 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=140 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=140 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=142 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
6 months minus baseline
|
-2.78 units on a scale
Standard Error 0.96
|
-4.52 units on a scale
Standard Error 0.95
|
-1.72 units on a scale
Standard Error 0.95
|
-2.40 units on a scale
Standard Error 0.94
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
12 months minus baseline
|
-6.60 units on a scale
Standard Error 1.21
|
-8.11 units on a scale
Standard Error 1.23
|
-4.29 units on a scale
Standard Error 1.20
|
-6.99 units on a scale
Standard Error 1.21
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
18 months minus baseline
|
-7.98 units on a scale
Standard Error 1.41
|
-10.21 units on a scale
Standard Error 1.43
|
-8.01 units on a scale
Standard Error 1.40
|
-9.32 units on a scale
Standard Error 1.42
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
24 months minus baseline
|
-12.82 units on a scale
Standard Error 1.68
|
-16.18 units on a scale
Standard Error 1.74
|
-11.88 units on a scale
Standard Error 1.66
|
-14.06 units on a scale
Standard Error 1.70
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
30 months minus baseline
|
-15.66 units on a scale
Standard Error 1.97
|
-19.67 units on a scale
Standard Error 2.06
|
-15.84 units on a scale
Standard Error 1.94
|
-18.30 units on a scale
Standard Error 1.97
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
36 months minus baseline
|
-18.89 units on a scale
Standard Error 2.32
|
-24.82 units on a scale
Standard Error 2.51
|
-19.71 units on a scale
Standard Error 2.34
|
-18.78 units on a scale
Standard Error 2.43
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
42 months minus baseline
|
-23.44 units on a scale
Standard Error 2.52
|
-28.13 units on a scale
Standard Error 2.76
|
-25.30 units on a scale
Standard Error 2.57
|
-23.48 units on a scale
Standard Error 2.65
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
48 months minus baseline
|
-29.25 units on a scale
Standard Error 3.08
|
-27.55 units on a scale
Standard Error 3.38
|
-26.55 units on a scale
Standard Error 3.11
|
-24.60 units on a scale
Standard Error 3.18
|
|
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
Average change from baseline
|
-15.20 units on a scale
Standard Error 1.11
|
-16.96 units on a scale
Standard Error 1.11
|
-13.81 units on a scale
Standard Error 1.11
|
-14.98 units on a scale
Standard Error 1.10
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baselinePopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline.
Outcome measures
| Measure |
Vitamin E + Memantine
n=136 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=137 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=136 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=140 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Mini-Mental State Examination Change From Baseline
6 months minus baseline
|
-0.20 units on a scale
Standard Error 0.29
|
-0.34 units on a scale
Standard Error 0.29
|
-0.35 units on a scale
Standard Error 0.29
|
-0.24 units on a scale
Standard Error 0.28
|
|
Mini-Mental State Examination Change From Baseline
12 months minus baseline
|
-0.65 units on a scale
Standard Error 0.34
|
-1.39 units on a scale
Standard Error 0.35
|
-0.95 units on a scale
Standard Error 0.34
|
-1.09 units on a scale
Standard Error 0.34
|
|
Mini-Mental State Examination Change From Baseline
18 months minus baseline
|
-1.22 units on a scale
Standard Error 0.44
|
-2.21 units on a scale
Standard Error 0.45
|
-2.00 units on a scale
Standard Error 0.44
|
-2.62 units on a scale
Standard Error 0.45
|
|
Mini-Mental State Examination Change From Baseline
24 months minus baseline
|
-2.29 units on a scale
Standard Error 0.53
|
-2.90 units on a scale
Standard Error 0.55
|
-2.62 units on a scale
Standard Error 0.52
|
-3.44 units on a scale
Standard Error 0.54
|
|
Mini-Mental State Examination Change From Baseline
30 months minus baseline
|
-3.16 units on a scale
Standard Error 0.61
|
-3.26 units on a scale
Standard Error 0.65
|
-3.67 units on a scale
Standard Error 0.61
|
-3.79 units on a scale
Standard Error 0.63
|
|
Mini-Mental State Examination Change From Baseline
36 months minus baseline
|
-3.69 units on a scale
Standard Error 0.73
|
-3.87 units on a scale
Standard Error 0.79
|
-4.97 units on a scale
Standard Error 0.74
|
-4.26 units on a scale
Standard Error 0.78
|
|
Mini-Mental State Examination Change From Baseline
42 months minus baseline
|
-3.80 units on a scale
Standard Error 0.74
|
-4.68 units on a scale
Standard Error 0.83
|
-4.84 units on a scale
Standard Error 0.79
|
-4.59 units on a scale
Standard Error 0.80
|
|
Mini-Mental State Examination Change From Baseline
48 months minus baseline
|
-5.70 units on a scale
Standard Error 0.91
|
-5.42 units on a scale
Standard Error 1.02
|
-5.26 units on a scale
Standard Error 0.94
|
-5.98 units on a scale
Standard Error 0.98
|
|
Mini-Mental State Examination Change From Baseline
Average change from baseline
|
-2.80 units on a scale
Standard Error 0.33
|
-3.16 units on a scale
Standard Error 0.33
|
-2.97 units on a scale
Standard Error 0.33
|
-3.05 units on a scale
Standard Error 0.33
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baselinePopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline.
Outcome measures
| Measure |
Vitamin E + Memantine
n=136 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=137 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=135 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=140 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
6 months minus baseline
|
1.53 units on a scale
Standard Error 0.63
|
3.04 units on a scale
Standard Error 0.63
|
1.38 units on a scale
Standard Error 0.63
|
1.11 units on a scale
Standard Error 0.62
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
12 months minus baseline
|
2.48 units on a scale
Standard Error 0.72
|
4.26 units on a scale
Standard Error 0.74
|
2.40 units on a scale
Standard Error 0.72
|
3.32 units on a scale
Standard Error 0.72
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
18 months minus baseline
|
3.46 units on a scale
Standard Error 0.90
|
6.04 units on a scale
Standard Error 0.92
|
4.34 units on a scale
Standard Error 0.91
|
5.69 units on a scale
Standard Error 0.91
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
24 months minus baseline
|
5.76 units on a scale
Standard Error 1.11
|
6.71 units on a scale
Standard Error 1.15
|
4.32 units on a scale
Standard Error 1.10
|
6.73 units on a scale
Standard Error 1.12
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
30 months minus baseline
|
5.85 units on a scale
Standard Error 1.30
|
8.90 units on a scale
Standard Error 1.38
|
7.87 units on a scale
Standard Error 1.31
|
7.64 units on a scale
Standard Error 1.34
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
36 months minus baseline
|
8.26 units on a scale
Standard Error 1.50
|
10.77 units on a scale
Standard Error 1.63
|
9.00 units on a scale
Standard Error 1.53
|
8.31 units on a scale
Standard Error 1.60
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
42 months minus baseline
|
7.97 units on a scale
Standard Error 1.51
|
10.61 units on a scale
Standard Error 1.69
|
10.35 units on a scale
Standard Error 1.60
|
8.24 units on a scale
Standard Error 1.64
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
48 months minus baseline
|
9.70 units on a scale
Standard Error 1.82
|
10.85 units on a scale
Standard Error 2.04
|
10.73 units on a scale
Standard Error 1.87
|
11.74 units on a scale
Standard Error 1.97
|
|
Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
Average change from baseline
|
6.13 units on a scale
Standard Error 0.71
|
7.78 units on a scale
Standard Error 0.70
|
5.97 units on a scale
Standard Error 0.70
|
6.38 units on a scale
Standard Error 0.70
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baselinePopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline.
Outcome measures
| Measure |
Vitamin E + Memantine
n=139 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=140 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=140 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=142 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Neuropsychiatric Inventory Change From Baseline
6 months minus baseline
|
-0.47 units on a scale
Standard Error 1.08
|
0.46 units on a scale
Standard Error 1.07
|
-1.24 units on a scale
Standard Error 1.07
|
-0.20 units on a scale
Standard Error 1.06
|
|
Neuropsychiatric Inventory Change From Baseline
12 months minus baseline
|
-0.17 units on a scale
Standard Error 1.22
|
1.08 units on a scale
Standard Error 1.24
|
-1.04 units on a scale
Standard Error 1.21
|
0.31 units on a scale
Standard Error 1.22
|
|
Neuropsychiatric Inventory Change From Baseline
18 months minus baseline
|
0.41 units on a scale
Standard Error 1.41
|
4.06 units on a scale
Standard Error 1.44
|
0.93 units on a scale
Standard Error 1.40
|
1.18 units on a scale
Standard Error 1.43
|
|
Neuropsychiatric Inventory Change From Baseline
24 months minus baseline
|
1.98 units on a scale
Standard Error 1.77
|
3.59 units on a scale
Standard Error 1.84
|
2.16 units on a scale
Standard Error 1.74
|
4.29 units on a scale
Standard Error 1.79
|
|
Neuropsychiatric Inventory Change From Baseline
30 months minus baseline
|
2.16 units on a scale
Standard Error 1.71
|
1.66 units on a scale
Standard Error 1.81
|
3.21 units on a scale
Standard Error 1.70
|
2.62 units on a scale
Standard Error 1.71
|
|
Neuropsychiatric Inventory Change From Baseline
36 months minus baseline
|
2.79 units on a scale
Standard Error 1.95
|
0.60 units on a scale
Standard Error 2.16
|
2.15 units on a scale
Standard Error 1.97
|
3.24 units on a scale
Standard Error 2.07
|
|
Neuropsychiatric Inventory Change From Baseline
42 months minus baseline
|
1.85 units on a scale
Standard Error 2.54
|
3.64 units on a scale
Standard Error 2.89
|
0.81 units on a scale
Standard Error 2.64
|
3.63 units on a scale
Standard Error 2.75
|
|
Neuropsychiatric Inventory Change From Baseline
48 months minus baseline
|
5.14 units on a scale
Standard Error 2.54
|
0.30 units on a scale
Standard Error 2.79
|
-0.60 units on a scale
Standard Error 2.53
|
2.79 units on a scale
Standard Error 2.60
|
|
Neuropsychiatric Inventory Change From Baseline
Average change from baseline
|
1.79 units on a scale
Standard Error 1.00
|
2.26 units on a scale
Standard Error 1.01
|
0.79 units on a scale
Standard Error 1.00
|
1.87 units on a scale
Standard Error 1.00
|
PRIMARY outcome
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baselinePopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline.
Outcome measures
| Measure |
Vitamin E + Memantine
n=139 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=140 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=140 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=142 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Caregiver Activity Survey Change From Baseline
6 months minus baseline
|
1.08 hours per day
Standard Error 0.83
|
1.20 hours per day
Standard Error 0.82
|
-0.93 hours per day
Standard Error 0.82
|
0.99 hours per day
Standard Error 0.81
|
|
Caregiver Activity Survey Change From Baseline
12 months minus baseline
|
1.39 hours per day
Standard Error 1.01
|
1.89 hours per day
Standard Error 1.04
|
-0.18 hours per day
Standard Error 1.00
|
2.72 hours per day
Standard Error 1.01
|
|
Caregiver Activity Survey Change From Baseline
18 months minus baseline
|
2.69 hours per day
Standard Error 1.20
|
3.16 hours per day
Standard Error 1.23
|
2.12 hours per day
Standard Error 1.20
|
3.77 hours per day
Standard Error 1.22
|
|
Caregiver Activity Survey Change From Baseline
24 months minus baseline
|
2.82 hours per day
Standard Error 1.11
|
3.45 hours per day
Standard Error 1.16
|
1.60 hours per day
Standard Error 1.09
|
3.06 hours per day
Standard Error 1.13
|
|
Caregiver Activity Survey Change From Baseline
30 months minus baseline
|
3.41 hours per day
Standard Error 1.24
|
4.36 hours per day
Standard Error 1.32
|
4.14 hours per day
Standard Error 1.22
|
5.22 hours per day
Standard Error 1.25
|
|
Caregiver Activity Survey Change From Baseline
36 months minus baseline
|
4.90 hours per day
Standard Error 2.24
|
10.68 hours per day
Standard Error 2.51
|
7.69 hours per day
Standard Error 2.30
|
5.72 hours per day
Standard Error 2.43
|
|
Caregiver Activity Survey Change From Baseline
42 months minus baseline
|
5.48 hours per day
Standard Error 1.73
|
10.62 hours per day
Standard Error 1.99
|
4.95 hours per day
Standard Error 1.81
|
9.46 hours per day
Standard Error 1.89
|
|
Caregiver Activity Survey Change From Baseline
48 months minus baseline
|
13.80 hours per day
Standard Error 2.74
|
12.17 hours per day
Standard Error 3.03
|
10.17 hours per day
Standard Error 2.74
|
9.27 hours per day
Standard Error 2.80
|
|
Caregiver Activity Survey Change From Baseline
Average change from baseline
|
5.00 hours per day
Standard Error 0.78
|
5.14 hours per day
Standard Error 0.79
|
3.35 hours per day
Standard Error 0.78
|
5.52 hours per day
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Every 6 months to a maximum of 4 yearsPopulation: Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.
The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5).
Outcome measures
| Measure |
Vitamin E + Memantine
n=139 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=140 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=140 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=142 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)
|
87 participants
|
79 participants
|
80 participants
|
87 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 yearsPopulation: Intention-to-treat analysis that includes all randomized participants.
Survival analysis of death from any cause.
Outcome measures
| Measure |
Vitamin E + Memantine
n=154 Participants
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=152 Participants
Matching placebo pills for vitamin E and memantine
|
Vitamin E
n=152 Participants
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=155 Participants
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
|---|---|---|---|---|
|
All-cause Mortality
|
32 participants
|
31 participants
|
26 participants
|
39 participants
|
Adverse Events
Vitamin E
Serious events: 82 serious events
Other events: 91 other events
Deaths: 0 deaths
Memantine
Serious events: 84 serious events
Other events: 97 other events
Deaths: 0 deaths
Vitamin E + Memantine
Serious events: 83 serious events
Other events: 90 other events
Deaths: 0 deaths
Placebo
Serious events: 95 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin E
n=152 participants at risk
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=155 participants at risk
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
Vitamin E + Memantine
n=154 participants at risk
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=152 participants at risk
Matching placebo pills for vitamin E and memantine
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Aphasia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Balance disorder
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Brain mass
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
2.6%
4/152 • Number of events 4
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Convulsion
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Nervous system disorders
Dementia Alzheimer's type
|
2.0%
3/152 • Number of events 3
|
1.9%
3/155 • Number of events 3
|
1.9%
3/154 • Number of events 3
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Headache
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Ischaemic stroke
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Syncope
|
1.3%
2/152 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
1.3%
2/154 • Number of events 2
|
2.6%
4/152 • Number of events 5
|
|
Nervous system disorders
Transient ischaemic attack
|
0.66%
1/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Aggression
|
1.3%
2/152 • Number of events 3
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
2.6%
4/152 • Number of events 4
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Mental status changes
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Psychotic behaviour
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Self injurious behaviour
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
2.0%
3/152 • Number of events 3
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Epididymitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/152 • Number of events 8
|
1.9%
3/155 • Number of events 3
|
1.3%
2/154 • Number of events 2
|
2.6%
4/152 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/152
|
1.3%
2/155 • Number of events 3
|
1.3%
2/154 • Number of events 2
|
2.6%
4/152 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Social circumstances
Respite care
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Social circumstances
Treatment noncompliance
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.66%
1/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Cardiac operation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 2
|
|
Surgical and medical procedures
Drug detoxification
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Hospice care
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 4
|
0.65%
1/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Renal stone removal
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Aortic aneurysm
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Aortic disorder
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Arteriosclerosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/152
|
1.9%
3/155 • Number of events 4
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 4
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Shock
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Thrombosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.3%
2/152 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac Disorders
|
12.5%
19/152 • Number of events 30
|
10.3%
16/155 • Number of events 23
|
12.3%
19/154 • Number of events 21
|
13.2%
20/152 • Number of events 26
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
8.6%
13/152 • Number of events 13
|
9.0%
14/155 • Number of events 18
|
7.8%
12/154 • Number of events 13
|
5.3%
8/152 • Number of events 10
|
|
General disorders
General Disorders
|
5.9%
9/152 • Number of events 9
|
4.5%
7/155 • Number of events 8
|
5.2%
8/154 • Number of events 10
|
9.2%
14/152 • Number of events 15
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Infections
|
12.5%
19/152 • Number of events 29
|
14.8%
23/155 • Number of events 31
|
20.1%
31/154 • Number of events 44
|
7.2%
11/152 • Number of events 13
|
|
Injury, poisoning and procedural complications
Injury or Procedural Complications
|
11.8%
18/152 • Number of events 22
|
9.7%
15/155 • Number of events 18
|
9.7%
15/154 • Number of events 17
|
11.8%
18/152 • Number of events 21
|
|
Investigations
Investigations
|
1.3%
2/152 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
2.6%
4/154 • Number of events 4
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
2.0%
3/152 • Number of events 4
|
4.5%
7/155 • Number of events 7
|
4.5%
7/154 • Number of events 9
|
3.9%
6/152 • Number of events 6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Acute coronary syndrome
|
0.66%
1/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
1/152 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
1.3%
2/152 • Number of events 4
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
2.0%
3/152 • Number of events 5
|
|
Cardiac disorders
Atrial flutter
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Bradycardia
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
3/152 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/152
|
1.9%
3/155 • Number of events 3
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
4/152 • Number of events 8
|
1.3%
2/155 • Number of events 2
|
2.6%
4/154 • Number of events 5
|
3.3%
5/152 • Number of events 7
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Cardiovascular disorder
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Cor pulmonale
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Coronary artery disease
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Mitral valve incompetence
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Myocardial infarction
|
3.9%
6/152 • Number of events 7
|
3.2%
5/155 • Number of events 5
|
1.9%
3/154 • Number of events 3
|
2.6%
4/152 • Number of events 5
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Eye disorders
Cataract
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/152 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
2/152 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Pharyngoesophageal diverticulum
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Adverse drug reaction
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Chest pain
|
2.0%
3/152 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 5
|
2.0%
3/152 • Number of events 4
|
|
General disorders
Complication of device insertion
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Cyst
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Death
|
1.3%
2/152 • Number of events 2
|
2.6%
4/155 • Number of events 4
|
0.65%
1/154 • Number of events 1
|
2.0%
3/152 • Number of events 3
|
|
General disorders
General physical health deterioration
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Hernia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Implant site pain
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Malaise
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Medical device complication
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Multi-organ failure
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Non-cardiac chest pain
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Oedema
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Stent-graft endoleak
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Sudden cardiac death
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Acarodermatitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Infections and infestations
Bronchitis
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Cellulitis
|
1.3%
2/152 • Number of events 2
|
1.9%
3/155 • Number of events 5
|
1.9%
3/154 • Number of events 3
|
0.00%
0/152
|
|
Infections and infestations
Cystitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Diverticulitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Ear infection
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Fungal infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Infected cyst
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Infection
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Latent tuberculosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Pneumonia
|
5.3%
8/152 • Number of events 11
|
5.2%
8/155 • Number of events 9
|
9.7%
15/154 • Number of events 15
|
3.3%
5/152 • Number of events 5
|
|
Infections and infestations
Sepsis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Sporotrichosis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Staphylococcal infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Tooth infection
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Urinary tract infection
|
5.3%
8/152 • Number of events 8
|
5.2%
8/155 • Number of events 8
|
4.5%
7/154 • Number of events 13
|
2.6%
4/152 • Number of events 5
|
|
Infections and infestations
Urosepsis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
9.9%
15/152 • Number of events 17
|
9.0%
14/155 • Number of events 16
|
7.8%
12/154 • Number of events 14
|
9.9%
15/152 • Number of events 18
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.0%
3/152 • Number of events 3
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Investigations
Blood glucose increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Bronchoscopy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Coagulation factor decreased
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Cystoscopy
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Electrocardiogram change
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Heart rate increased
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Heart rate irregular
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Urine output decreased
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Weight decreased
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/152 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 3
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
1.9%
3/154 • Number of events 3
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/152
|
1.9%
3/155 • Number of events 3
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
2.6%
4/152 • Number of events 4
|
4.5%
7/155 • Number of events 8
|
2.6%
4/154 • Number of events 6
|
3.9%
6/152 • Number of events 6
|
|
Nervous system disorders
Nervous System Disorders
|
7.9%
12/152 • Number of events 15
|
9.7%
15/155 • Number of events 18
|
11.0%
17/154 • Number of events 18
|
12.5%
19/152 • Number of events 21
|
|
Psychiatric disorders
Psychiatric Disorders
|
5.3%
8/152 • Number of events 10
|
6.5%
10/155 • Number of events 10
|
3.2%
5/154 • Number of events 7
|
3.3%
5/152 • Number of events 5
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
1.3%
2/152 • Number of events 2
|
3.2%
5/155 • Number of events 5
|
2.6%
4/154 • Number of events 4
|
3.9%
6/152 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorders
|
3.3%
5/152 • Number of events 12
|
5.8%
9/155 • Number of events 11
|
4.5%
7/154 • Number of events 8
|
7.2%
11/152 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Skin Disorders
|
0.00%
0/152
|
0.65%
1/155 • Number of events 3
|
0.00%
0/154
|
0.00%
0/152
|
|
Social circumstances
Social Circumstances
|
0.66%
1/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
5.9%
9/152 • Number of events 10
|
3.2%
5/155 • Number of events 7
|
3.2%
5/154 • Number of events 6
|
3.3%
5/152 • Number of events 6
|
|
Vascular disorders
Vascular Disorders
|
2.6%
4/152 • Number of events 4
|
3.2%
5/155 • Number of events 6
|
3.9%
6/154 • Number of events 9
|
3.9%
6/152 • Number of events 6
|
Other adverse events
| Measure |
Vitamin E
n=152 participants at risk
Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
|
Memantine
n=155 participants at risk
Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
|
Vitamin E + Memantine
n=154 participants at risk
2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
|
Placebo
n=152 participants at risk
Matching placebo pills for vitamin E and memantine
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
0.66%
1/152 • Number of events 2
|
|
Psychiatric disorders
Nightmare
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Renal and urinary disorders
Haematuria
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Renal failure chronic
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
3/152 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
3/152 • Number of events 3
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/152
|
1.9%
3/155 • Number of events 3
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Dialysis
|
0.00%
0/152
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Surgical and medical procedures
Emergency care
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Aortic aneurysm
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Hypertension
|
0.66%
1/152 • Number of events 1
|
1.9%
3/155 • Number of events 3
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Hypotension
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
2/152 • Number of events 2
|
1.9%
3/155 • Number of events 3
|
1.3%
2/154 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Eye disorders
Blindness
|
0.00%
0/152
|
1.3%
2/155 • Number of events 3
|
0.00%
0/154
|
0.00%
0/152
|
|
Eye disorders
Cataract
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Eye disorders
Dry eye
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Eye disorders
Entropion
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Eye disorders
Macular degeneration
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Refraction disorder
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Eye disorders
Vision blurred
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
7/152 • Number of events 8
|
2.6%
4/155 • Number of events 8
|
5.2%
8/154 • Number of events 8
|
3.3%
5/152 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/152
|
0.65%
1/155 • Number of events 2
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Toothache
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Asthenia
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Chest pain
|
0.66%
1/152 • Number of events 2
|
1.3%
2/155 • Number of events 2
|
1.9%
3/154 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Cyst
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
General disorders
Device occlusion
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Fatigue
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Hernia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Influenza like illness
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Irritability
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Oedema peripheral
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Xerosis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Abscess oral
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Infections and infestations
Cellulitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Furuncle
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Gastric infection
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Hordeolum
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Influenza
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Lung infection
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Nasopharyngitis
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Onychomycosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Orchitis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Otitis externa
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Paronychia
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
1.9%
3/154 • Number of events 3
|
0.00%
0/152
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Sepsis
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Tinea cruris
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Tracheobronchitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Infections and infestations
Upper respiratory tract infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/152 • Number of events 2
|
3.2%
5/155 • Number of events 6
|
3.9%
6/154 • Number of events 7
|
1.3%
2/152 • Number of events 3
|
|
Infections and infestations
Viral infection
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug prescribing error
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Exposure to chemical pollution
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Face injury
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Fall
|
20.4%
31/152 • Number of events 58
|
18.1%
28/155 • Number of events 39
|
24.0%
37/154 • Number of events 65
|
20.4%
31/152 • Number of events 48
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Injury
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
3.2%
5/154 • Number of events 5
|
1.3%
2/152 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Blood albumin abnormal
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Blood bicarbonate increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Blood cholesterol increased
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Blood creatinine increased
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Blood glucose increased
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
1.9%
3/154 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood homocysteine increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Culture negative
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Full blood count increased
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Heart rate decreased
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Investigations
Laboratory test abnormal
|
2.6%
4/152 • Number of events 4
|
3.2%
5/155 • Number of events 5
|
1.9%
3/154 • Number of events 4
|
2.0%
3/152 • Number of events 3
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Weight decreased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Dehydration
|
0.66%
1/152 • Number of events 1
|
1.9%
3/155 • Number of events 4
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/152 • Number of events 4
|
1.9%
3/155 • Number of events 3
|
0.00%
0/154
|
2.0%
3/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.66%
1/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/152
|
1.3%
2/155 • Number of events 3
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
1.3%
2/152 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 2
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Aphasia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Cerebrovascular accident
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Dementia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Dizziness
|
3.9%
6/152 • Number of events 6
|
4.5%
7/155 • Number of events 8
|
3.2%
5/154 • Number of events 5
|
2.0%
3/152 • Number of events 3
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Dyskinesia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Headache
|
0.66%
1/152 • Number of events 1
|
2.6%
4/155 • Number of events 5
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Hemiparesis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/152
|
1.3%
2/155 • Number of events 2
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Mental impairment
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Radial nerve palsy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Somnolence
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
1.9%
3/154 • Number of events 3
|
2.0%
3/152 • Number of events 4
|
|
Nervous system disorders
Tremor
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Abnormal behaviour
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
1.3%
2/154 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Abnormal sleep-related event
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Aggression
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
1.3%
2/152 • Number of events 2
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/152
|
0.00%
0/155
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.66%
1/152 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Apathy
|
0.00%
0/152
|
0.00%
0/155
|
0.65%
1/154 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Confusional state
|
1.3%
2/152 • Number of events 2
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.00%
0/152
|
|
Psychiatric disorders
Delusion
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/152
|
0.65%
1/155 • Number of events 1
|
0.00%
0/154
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Disorientation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/155
|
0.00%
0/154
|
0.00%
0/152
|
|
Psychiatric disorders
Hallucination
|
0.66%
1/152 • Number of events 1
|
0.65%
1/155 • Number of events 1
|
1.3%
2/154 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
Additional Information
Peter Guarino, PhD, Director WH-CSPCC
Dept. of Veterans Affairs Cooperative Stduies Program
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place