Trial Outcomes & Findings for Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease (NCT NCT01409915)
NCT ID: NCT01409915
Last Updated: 2021-06-02
Results Overview
Count of AE's from Consent to Follow-up 2 within a safety analysis set consisting of all participants who were enrolled and randomized and who received at least one injection of sargramostim or placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
20 weeks (From Consent to Follow-up 2)
Results posted on
2021-06-02
Participant Flow
Participant milestones
| Measure |
Sagramostim (Leukine)
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Sagramostim (Leukine)
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.10 Years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
70.15 Years
STANDARD_DEVIATION 6.42 • n=7 Participants
|
68.63 Years
STANDARD_DEVIATION 6.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · White / Caucasian
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Black / African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Asian / Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Hispanic / Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education Level (Mean years)
|
15.70 Years
STANDARD_DEVIATION 2.92 • n=5 Participants
|
15.80 Years
STANDARD_DEVIATION 2.71 • n=7 Participants
|
15.75 Years
STANDARD_DEVIATION 2.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeks (From Consent to Follow-up 2)Population: Safety analysis set (SAS), all participants enrolled and randomized and who received at least one injection of sargramostim or placebo
Count of AE's from Consent to Follow-up 2 within a safety analysis set consisting of all participants who were enrolled and randomized and who received at least one injection of sargramostim or placebo
Outcome measures
| Measure |
Sagramostim (Leukine)
n=21 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=22 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Adverse Events (AEs) by Body System
Cardiovascular AE
|
5 Adverse Events
|
2 Adverse Events
|
|
Adverse Events (AEs) by Body System
Constitutional
|
6 Adverse Events
|
5 Adverse Events
|
|
Adverse Events (AEs) by Body System
Dental
|
1 Adverse Events
|
0 Adverse Events
|
|
Adverse Events (AEs) by Body System
Dermatological
|
16 Adverse Events
|
5 Adverse Events
|
|
Adverse Events (AEs) by Body System
ENT
|
2 Adverse Events
|
0 Adverse Events
|
|
Adverse Events (AEs) by Body System
Gastrointestinal
|
8 Adverse Events
|
5 Adverse Events
|
|
Adverse Events (AEs) by Body System
Musculoskeletal
|
8 Adverse Events
|
11 Adverse Events
|
|
Adverse Events (AEs) by Body System
Neurological
|
9 Adverse Events
|
2 Adverse Events
|
|
Adverse Events (AEs) by Body System
Psychological
|
0 Adverse Events
|
2 Adverse Events
|
|
Adverse Events (AEs) by Body System
Respiratory
|
4 Adverse Events
|
4 Adverse Events
|
SECONDARY outcome
Timeframe: From Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment)Population: The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
Mini-Mental State Examination (MMSE) is a brief psychometric instrument developed to assess cognitive function in elderly populations. It is a standard assessment used by all NIH Alzheimer's Disease Centers (ADCCs and ADRCs) to identify and monitor individuals with AD. The range for scores in the MMSE is from 0 to 30, with lower scores indicating greater impairment.
Outcome measures
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
MMSE (Mini Mental State Examination) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Baseline
|
17.10 score on a scale
Standard Deviation 4.57
|
20.75 score on a scale
Standard Deviation 4.97
|
|
MMSE (Mini Mental State Examination) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
End of Treatment (3 weeks)
|
18.55 score on a scale
Standard Deviation 4.99
|
20.40 score on a scale
Standard Deviation 5.28
|
|
MMSE (Mini Mental State Examination) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 1 (45 days post treatment)
|
18.00 score on a scale
Standard Deviation 5.52
|
19.90 score on a scale
Standard Deviation 5.19
|
|
MMSE (Mini Mental State Examination) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 2 (90 days pot treatment)
|
17.10 score on a scale
Standard Deviation 5.78
|
19.40 score on a scale
Standard Deviation 5.47
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment)Population: The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog13). The ADAS-Cog13 is the most popular cognitive testing instrument used in clinical trials of nootropics (drugs or agents that improve cognitive function). It consists of 13 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities, which are often referred to as the core symptoms of AD. Score ranges from 0-85, with a higher score representing more severe impairment
Outcome measures
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Baseline
|
43.20 units on a scale
Standard Deviation 12.45
|
36.20 units on a scale
Standard Deviation 12.01
|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
End of Treatment (3 weeks)
|
43.54 units on a scale
Standard Deviation 12.02
|
36.68 units on a scale
Standard Deviation 11.63
|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 1 (45 days post treatment)
|
47.67 units on a scale
Standard Deviation 11.89
|
36.33 units on a scale
Standard Deviation 9.85
|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 2 (90 days post treatment)
|
45.87 units on a scale
Standard Deviation 13.21
|
36.85 units on a scale
Standard Deviation 10.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment)Population: The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
The ADCS-ADL is a caregiver/study partner rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. The ADCS-ADL assesses functional capacity across a wide spectrum of severity
Outcome measures
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Baseline
|
56.50 score on a scale
Standard Deviation 12.30
|
62.75 score on a scale
Standard Deviation 8.98
|
|
Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
End of Treatment (3 weeks)
|
57.00 score on a scale
Standard Deviation 11.93
|
61.85 score on a scale
Standard Deviation 9.32
|
|
Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 1 (45 days post treatment)
|
53.35 score on a scale
Standard Deviation 14.02
|
59.85 score on a scale
Standard Deviation 9.05
|
|
Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 2 (90 days post treatment)
|
53.30 score on a scale
Standard Deviation 15.00
|
60.30 score on a scale
Standard Deviation 9.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment)Population: The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
The CDR is a study partner/caregiver and participant based interview to assess changes in domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated as 0 (no dementia), 0.5 (uncertain dementia), 1 (mild dementia), 2 (moderate dementia), or 3 (severe dementia). The Sum of Boxes score (CDR-SB) score was tallied for each administration using the rules from the Washington University Knight ADRD scoring algorithm. Scores range from 0-18. The higher the score, the worse the impairment.
Outcome measures
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Baseline
|
7.10 units on a scale
Standard Deviation 3.32
|
6.10 units on a scale
Standard Deviation 2.67
|
|
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
End of Treatment (3 weeks)
|
7.53 units on a scale
Standard Deviation 3.37
|
5.95 units on a scale
Standard Deviation 2.37
|
|
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 1 (45 days post treatment)
|
8.42 units on a scale
Standard Deviation 4.22
|
6.81 units on a scale
Standard Deviation 3.12
|
|
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 2 (90 days post treatment)
|
8.57 units on a scale
Standard Deviation 4.14
|
7.03 units on a scale
Standard Deviation 3.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment)Population: The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
The Trail Making Test- part A (TMT-A) is a assessment of psychomotor speed and is a timed test in which participants must connect a series of numbers randomly placed on a page. Time range is between 0 and 150 seconds, with higher score representing worse performance.
Outcome measures
| Measure |
Sagramostim (Leukine)
n=20 Participants
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=20 Participants
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Baseline
|
101.50 units on a scale
Standard Deviation 46.17
|
84.85 units on a scale
Standard Deviation 48.83
|
|
Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
End of Treatment (3 weeks)
|
92.60 units on a scale
Standard Deviation 45.49
|
79.40 units on a scale
Standard Deviation 44.56
|
|
Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 1 (45 days post treatment)
|
107.85 units on a scale
Standard Deviation 45.81
|
84.00 units on a scale
Standard Deviation 45.64
|
|
Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)
Follow-up 2 (90 days post treatment)
|
110.35 units on a scale
Standard Deviation 45.55
|
85.45 units on a scale
Standard Deviation 48.10
|
Adverse Events
Sagramostim (Leukine)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sagramostim (Leukine)
n=21 participants at risk
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=23 participants at risk
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
4.8%
1/21 • Number of events 1 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.3%
1/23 • Number of events 1 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
Sagramostim (Leukine)
n=21 participants at risk
250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
|
Control Group
n=23 participants at risk
Saline placebo comparator: subcutaneous injection
|
|---|---|---|
|
General disorders
Fatigue
|
9.5%
2/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
17.4%
4/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
42.9%
9/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
21.7%
5/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
4.3%
1/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
13.0%
3/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Pain/Myalgia
|
19.0%
4/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
21.7%
5/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
4.8%
1/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
17.4%
4/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Nervous system disorders
Headache, Benign NOS
|
38.1%
8/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
8.7%
2/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory infection
|
14.3%
3/21 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
13.0%
3/23 • Adverse events were completed over a 20 week period, from Consent to Follow-up 2
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
John O'Shaughnessy, MS, Clinical Research Services Principal Professional
University of Colorado Denver | Anschutz Medical Campus
Phone: 3037247924
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place