Trial Outcomes & Findings for Medication Treatment for Depression in Nursing Home Residents (NCT NCT00076622)
NCT ID: NCT00076622
Last Updated: 2018-01-31
Results Overview
The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).
Recruitment status
COMPLETED
Target enrollment
94 participants
Primary outcome timeframe
Measured at Month 12
Results posted on
2018-01-31
Participant Flow
Participant milestones
| Measure |
Randomized to Drug Continuation
Participants assigned to continue current antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Randomized to Drug Discontinuation
Participants assigned to discontinue current antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participant Preference to Continue Drug
Chose to continue antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participant Preference to Discontinue Drug
Chose to stop antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
13
|
40
|
18
|
|
Overall Study
COMPLETED
|
23
|
13
|
40
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication Treatment for Depression in Nursing Home Residents
Baseline characteristics by cohort
| Measure |
Randomized to Drug Continuation
n=23 Participants
Participants assigned to continue current antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Randomized to Drug Discontinuation
n=13 Participants
Participants assigned to discontinue current antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participant Preference to Continue Drug
n=40 Participants
Chose to continue antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participant Preference to Discontinue Drug
n=18 Participants
Chose to stop antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Geriatric Depression Scale
|
4.3 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 2.7 • n=21 Participants
|
|
Cognitive function (MMSE)
|
23.1 units on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
24.9 units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
24.3 units on a scale
STANDARD_DEVIATION 4.5 • n=4 Participants
|
24.1 units on a scale
STANDARD_DEVIATION 4.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 12The GDS scale measures presence and severity of depressive symptoms in older adults. Scores range from zero (no depression symptoms) to thirty (severe depression symptoms).
Outcome measures
| Measure |
Randomized Arm-continue
n=23 Participants
Participants who agreed to be randomized were assigned to the continuation antidepressant
|
Randomized Arm-discontinue
n=13 Participants
Those who were randomized to discontinue anti depressants
|
Non Randomized/Preference Arm-continue
n=40 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
|
Non-Randomized Preference-discontinue
n=18 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
|
|---|---|---|---|---|
|
Geriatric Depression Scale (GDS) Score
|
5.11 units on a scale
Standard Deviation 0.86
|
5.03 units on a scale
Standard Deviation 1.15
|
4.59 units on a scale
Standard Deviation 0.49
|
4.64 units on a scale
Standard Deviation 0.75
|
PRIMARY outcome
Timeframe: Measured from Baseline through Month TwelveOutcome measures
| Measure |
Randomized Arm-continue
n=23 Participants
Participants who agreed to be randomized were assigned to the continuation antidepressant
|
Randomized Arm-discontinue
n=13 Participants
Those who were randomized to discontinue anti depressants
|
Non Randomized/Preference Arm-continue
n=40 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
|
Non-Randomized Preference-discontinue
n=18 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
|
|---|---|---|---|---|
|
Number of Falls Experienced by Participants Over Twelve Months of Surveillance
|
12 number of falls
|
9 number of falls
|
26 number of falls
|
10 number of falls
|
SECONDARY outcome
Timeframe: Measured at Month 12The Mini Mental State Examination (MMSE) measures cognitive function in multiple domains, including memory, orientation, language, and executive function. Scores range from zero (severe cognitive impairment) to thirty (intact cognitive function).
Outcome measures
| Measure |
Randomized Arm-continue
n=23 Participants
Participants who agreed to be randomized were assigned to the continuation antidepressant
|
Randomized Arm-discontinue
n=13 Participants
Those who were randomized to discontinue anti depressants
|
Non Randomized/Preference Arm-continue
n=40 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to continue and were assigned to those groups based on their non-random choice.
|
Non-Randomized Preference-discontinue
n=18 Participants
Those individuals who refused randomization were offered participation based on their preference (or a proxy/family member's preference, or their doctor's preference) to discontinue, and were assigned to those groups based on their non-random choice.
|
|---|---|---|---|---|
|
Cognitive Function (MMSE)
|
23.1 units on a scale
Standard Deviation 4.4
|
24.9 units on a scale
Standard Deviation 4.0
|
24.4 units on a scale
Standard Deviation 3.7
|
24.3 units on a scale
Standard Deviation 4.5
|
Adverse Events
Randomized to Drug Continuation
Serious events: 8 serious events
Other events: 21 other events
Deaths: 1 deaths
Randomized to Discontinuation
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Participation Based Upon Preference (Continue)
Serious events: 14 serious events
Other events: 33 other events
Deaths: 1 deaths
Participation Based Upon Preference (Discontinue)
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Randomized to Drug Continuation
n=23 participants at risk
Participants assigned to continue current antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Randomized to Discontinuation
n=13 participants at risk
Participants assigned to discontinue current antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participation Based Upon Preference (Continue)
n=40 participants at risk
Chose to continue antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participation Based Upon Preference (Discontinue)
n=18 participants at risk
Chose to stop antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
|---|---|---|---|---|
|
General disorders
hospitalization
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Cardiac disorders
bradycardia
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Metabolism and nutrition disorders
dehydration
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Injury, poisoning and procedural complications
polytrauma from motor vehicle accident
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Cardiac disorders
myocardial infarction
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Immune system disorders
allergic reaction
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
General disorders
unstable angina with aspiration pneumonia
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
7.5%
3/40 • Number of events 3 • 12 months
|
11.1%
2/18 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
small bowel obstruction
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Reproductive system and breast disorders
breast cancer
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
General disorders
syncope
|
0.00%
0/23 • 12 months
|
23.1%
3/13 • Number of events 3 • 12 months
|
2.5%
1/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Infections and infestations
bronchitis
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Infections and infestations
cellulitis
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
hip dislocation
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Injury, poisoning and procedural complications
humerus fracture
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Nervous system disorders
transient ischemic attack
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Gastrointestinal disorders
tarry stool
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
toxic metabolic encephalopathy
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
weight loss
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Randomized to Drug Continuation
n=23 participants at risk
Participants assigned to continue current antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Randomized to Discontinuation
n=13 participants at risk
Participants assigned to discontinue current antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participation Based Upon Preference (Continue)
n=40 participants at risk
Chose to continue antidepressant medication
Antidepressant medication: Participants assigned to continue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
Participation Based Upon Preference (Discontinue)
n=18 participants at risk
Chose to stop antidepressant medication
No antidepressant medication: Participants assigned to discontinue current medication will be monitored over a period of one year for recurrence of depression and related symptoms.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
17.4%
4/23 • Number of events 5 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
General disorders
fall
|
47.8%
11/23 • Number of events 17 • 12 months
|
53.8%
7/13 • Number of events 20 • 12 months
|
55.0%
22/40 • Number of events 78 • 12 months
|
61.1%
11/18 • Number of events 19 • 12 months
|
|
Infections and infestations
upper respiratory infection
|
21.7%
5/23 • Number of events 6 • 12 months
|
53.8%
7/13 • Number of events 10 • 12 months
|
15.0%
6/40 • Number of events 8 • 12 months
|
27.8%
5/18 • Number of events 7 • 12 months
|
|
Infections and infestations
urinary tract infection
|
13.0%
3/23 • Number of events 4 • 12 months
|
38.5%
5/13 • Number of events 5 • 12 months
|
25.0%
10/40 • Number of events 18 • 12 months
|
11.1%
2/18 • Number of events 5 • 12 months
|
|
Psychiatric disorders
depression
|
0.00%
0/23 • 12 months
|
30.8%
4/13 • Number of events 5 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
skin tear
|
8.7%
2/23 • Number of events 2 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
16.7%
3/18 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
vomiting /nausea
|
13.0%
3/23 • Number of events 3 • 12 months
|
15.4%
2/13 • Number of events 2 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
16.7%
3/18 • Number of events 4 • 12 months
|
|
Skin and subcutaneous tissue disorders
abrasion
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
General disorders
anemia
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
abscess
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
8.7%
2/23 • Number of events 2 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
cellulitis
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
clostridium difficile infection
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colonic polyps
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Cardiac disorders
congestive heart failure
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
decubitus ulcer
|
4.3%
1/23 • Number of events 1 • 12 months
|
15.4%
2/13 • Number of events 2 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
General disorders
dizziness
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
16.7%
3/18 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
duodenal ulcer
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
dental infection
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
General disorders
epistaxis
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
flank pain
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
gastrointestinal bleeding
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
gout
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Nervous system disorders
headache
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
11.1%
2/18 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
hemorrhoids
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
herpes simplex
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Infections and infestations
herpes zoster
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
hepatitis C
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
General disorders
leg edema
|
8.7%
2/23 • Number of events 2 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Nervous system disorders
neuropathic pain
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Eye disorders
ophthalmic infection
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Vascular disorders
orthostatic hypotension
|
8.7%
2/23 • Number of events 2 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Psychiatric disorders
mental status change
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Infections and infestations
pneumonia
|
0.00%
0/23 • 12 months
|
15.4%
2/13 • Number of events 2 • 12 months
|
7.5%
3/40 • Number of events 3 • 12 months
|
0.00%
0/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
13.0%
3/23 • Number of events 3 • 12 months
|
0.00%
0/13 • 12 months
|
7.5%
3/40 • Number of events 3 • 12 months
|
11.1%
2/18 • Number of events 2 • 12 months
|
|
Vascular disorders
transient ischemic attack
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Injury, poisoning and procedural complications
tooth fracture
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
0.00%
0/40 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
skin blister
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
2.5%
1/40 • Number of events 1 • 12 months
|
5.6%
1/18 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer
|
0.00%
0/23 • 12 months
|
0.00%
0/13 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
0.00%
0/18 • 12 months
|
|
Musculoskeletal and connective tissue disorders
vertebral compression fracture
|
4.3%
1/23 • Number of events 1 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/23 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
0.00%
0/40 • 12 months
|
0.00%
0/18 • 12 months
|
|
Metabolism and nutrition disorders
weight loss
|
8.7%
2/23 • Number of events 2 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
5.0%
2/40 • Number of events 2 • 12 months
|
11.1%
2/18 • Number of events 2 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place