Trial Outcomes & Findings for Phase IIa L-serine Trial for eAD (NCT NCT03062449)
NCT ID: NCT03062449
Last Updated: 2024-07-03
Results Overview
Cognitive Assessment will be performed and score obtained at clinical trial visits. The Montreal Cognitive Assessment or The MoCA Test is a highly sensitive tool for early detection of mild cognitive impairment. The assessment evaluates eight domains of cognitive functions, including visuospatial and executive function, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline, 6 Months, 9 Months
Results posted on
2024-07-03
Participant Flow
The study was placed on voluntary hold by the institution prior to study completion. Upon review of the stability data of the investigational agent provided by the product's manufacturer, the FDA IND Sponsor-Investigator (PI) and institutional officials determined that the available information was unsatisfactory. No reportable study outcome data are available as determined by the institution and Sponsor-Investigator (PI) because the stability of the investigational product cannot be verified.
Study participants are grouped for the participant flow. The study was closed by the Sponsor-Investigator and institution prior to study completion because the stability of the investigational product could not be verified.
Participant milestones
| Measure |
L-Serine Gummy Arm
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
Completed Treatment
|
10
|
12
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
L-Serine Gummy Arm
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
Baseline Characteristics
Phase IIa L-serine Trial for eAD
Baseline characteristics by cohort
| Measure |
L-serine Gummy Arm
n=16 Participants
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=13 Participants
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
Total
n=29 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 Months, 9 MonthsPopulation: Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time. No reportable study outcome data are available.
Cognitive Assessment will be performed and score obtained at clinical trial visits. The Montreal Cognitive Assessment or The MoCA Test is a highly sensitive tool for early detection of mild cognitive impairment. The assessment evaluates eight domains of cognitive functions, including visuospatial and executive function, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
Outcome measures
| Measure |
L-Serine Gummy Arm
n=16 Participants
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=13 Participants
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Change in Score on the Montreal Cognitive Assessment Assessment Evaluation
Baseline
|
20.625 score on a scale
Interval 16.0 to 25.0
|
22.923 score on a scale
Interval 14.0 to 30.0
|
|
Change in Score on the Montreal Cognitive Assessment Assessment Evaluation
6 Months
|
19.846 score on a scale
Interval 12.0 to 24.0
|
21.909 score on a scale
Interval 15.0 to 28.0
|
|
Change in Score on the Montreal Cognitive Assessment Assessment Evaluation
9 Months
|
20.3 score on a scale
Interval 14.0 to 27.0
|
21.5 score on a scale
Interval 13.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline, 6 Months, 9 monthsPopulation: Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time. The biomarker data does not exist.
Levels of biomarkers related to cognitive status will be assessed in plasma that was collected at clinical trial visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 Months, 9 monthsPopulation: Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time. The biomarker data does not exist.
Disease status biomarker levels will be assessed in plasma at trial visits. Montreal Cognitive Assessment testing will be performed and scored at each visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks (+/- 2 weeks) after visit 4 (week 36 +/- 2 weeks)Population: Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by Sponsor-Investigator (PI) and institutional officials. The study was closed by PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer, as PI is unable to confirm that investigational product remained stable over time. Only 10 participants from L-serine and 7 from placebo group completed the assessment.
Each participant will report tolerability on a scale of 1 to 10 (1 = poor and 10 = excellent). This assessment was completed at the end of participation via a phone calls 4 weeks after visit 4.
Outcome measures
| Measure |
L-Serine Gummy Arm
n=10 Participants
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=7 Participants
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Self-reported L-serine Tolerability
|
8 units on a scale
Interval 1.0 to 10.0
|
8 units on a scale
Interval 1.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 Months, 6 Months, 9 monthsPopulation: Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time. The number of participants analyzed decreased over time due to participants withdrawing or being withdrawn by the PI.
Health check labs will be collected from every participant at each clinical trial visit. clinically significant lab values will be identified for complete blood count, liver function test, and basic metabolic panel measures.
Outcome measures
| Measure |
L-Serine Gummy Arm
n=16 Participants
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=13 Participants
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.
Baseline
|
0 # of clinically significant lab values
|
0 # of clinically significant lab values
|
|
Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.
3 Months
|
0 # of clinically significant lab values
|
0 # of clinically significant lab values
|
|
Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.
6 Months
|
0 # of clinically significant lab values
|
0 # of clinically significant lab values
|
|
Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.
9 Months
|
0 # of clinically significant lab values
|
0 # of clinically significant lab values
|
Adverse Events
L-Serine: Gummy Arm
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Gummy Arm
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L-Serine: Gummy Arm
n=16 participants at risk
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=13 participants at risk
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
General disorders
chest pain
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 3 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
Other adverse events
| Measure |
L-Serine: Gummy Arm
n=16 participants at risk
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
L-Serine: Gummy containing L serine dose
|
Placebo Gummy Arm
n=13 participants at risk
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
Placebo Gummy: Gummy with no dosing of L Serine
|
|---|---|---|
|
Nervous system disorders
movement disorder
|
6.2%
1/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
skin lesion or rash
|
25.0%
4/16 • Number of events 4 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
sleep disturbance
|
18.8%
3/16 • Number of events 5 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Investigations
weight gain
|
18.8%
3/16 • Number of events 4 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
23.1%
3/13 • Number of events 3 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Eye disorders
cataract extraction
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
syncope
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Cardiac disorders
bradycardia
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
diarrhea
|
31.2%
5/16 • Number of events 6 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
cognitive decline
|
18.8%
3/16 • Number of events 3 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
53.8%
7/13 • Number of events 8 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Investigations
weight loss
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
anxiety
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
dog bite
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
tic bite
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
potential overdose
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Musculoskeletal and connective tissue disorders
atrophy of hands
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Infections and infestations
pneumonia
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Vascular disorders
leg edema
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Vascular disorders
pulmonary vascular congestion
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Infections and infestations
cellulitis
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
recurrent major depressive disorder
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
taste change
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Metabolism and nutrition disorders
reduced appetite
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
nausea
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
gas
|
6.2%
1/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Blood and lymphatic system disorders
reduced platelets
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
change in bowel habits
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
headache
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Infections and infestations
upper respiratory infection
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
General disorders
fatigue
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
peripheral neuropathy
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Eye disorders
worsening vision secondary to left cataract
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Surgical and medical procedures
dental procedure
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Vascular disorders
blood pressure elevation
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Reproductive system and breast disorders
focal pain above left breast
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Ear and labyrinth disorders
right hearing impairment
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
General disorders
cold
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
puncture wound left foot
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
irritability
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
15.4%
2/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Nervous system disorders
lightheadedness
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
12.5%
2/16 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Eye disorders
flashing lights at night
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
feeling sped up
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Infections and infestations
right ear infection
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
0.00%
0/13 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Musculoskeletal and connective tissue disorders
gout
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
lack of motivation
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
soft tissue injury due to fall
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 2 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
6.2%
1/16 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Psychiatric disorders
increased restlessness
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Vascular disorders
hot flashes
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
|
Injury, poisoning and procedural complications
falls, no injury
|
0.00%
0/16 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
7.7%
1/13 • Number of events 1 • Investigational agent stability data provided by product's manufacturer was determined to be unsatisfactory by the Sponsor-Investigator (PI) and institutional officials. Study was closed by the PI and institution prior to study completion. Data are potentially invalid due to inadequate stability testing performed by the manufacturer; the sponsor-investigator is unable to confirm that investigational product remained stable overtime. Adverse event data were collected over approximately 4 months.
Due to the inability to confirm adherence with the study treatment (Gummy Bears) by the subjects enrolled in the study, the attribution of any adverse events (including serious events) to study treatment is not possible. Thus, adverse events are being reported in aggregate.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place