Trial Outcomes & Findings for Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention (NCT NCT01661764)

Results Overview

The primary outcome of interest is rectal epithelial cell proliferation, as measured by Ki67 (mib-1) labeling. Expression of Ki-67 in colon epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

141 participants

Primary outcome timeframe

6 month

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	rs174535 (GG), Fish Oil Supplements Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo Oleic Acid Oleic Acid: Placebo
Overall Study STARTED	26	25	25	26	19	20
Overall Study COMPLETED	24	20	22	24	16	18
Overall Study NOT COMPLETED	2	5	3	2	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fish Oil Supplementation, Nutrigenomics and Colorectal Cancer Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rs174535 (GG), Fish Oil Supplements n=26 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=25 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=25 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=26 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=19 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	Total n=141 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 6.7 • n=5 Participants	60 years STANDARD_DEVIATION 8.3 • n=7 Participants	59.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	58.9 years STANDARD_DEVIATION 7.4 • n=4 Participants	60.5 years STANDARD_DEVIATION 9.8 • n=21 Participants	61.6 years STANDARD_DEVIATION 7.6 • n=8 Participants	59.6 years STANDARD_DEVIATION 8.2 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	68 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants	14 Participants n=4 Participants	11 Participants n=21 Participants	12 Participants n=8 Participants	73 Participants n=8 Participants

PRIMARY outcome

Timeframe: 6 month

Population: Patients with before and after rectal biopsies

The primary outcome of interest is rectal epithelial cell proliferation, as measured by Ki67 (mib-1) labeling. Expression of Ki-67 in colon epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
Rectal Epithelial Cell Proliferation	19.3 percentage of cells positive Standard Deviation 6.8	20.3 percentage of cells positive Standard Deviation 7.6	18.9 percentage of cells positive Standard Deviation 8.5	16.8 percentage of cells positive Standard Deviation 6.2	15.7 percentage of cells positive Standard Deviation 5.4	20.8 percentage of cells positive Standard Deviation 6.7

PRIMARY outcome

Timeframe: 6 months

The primary outcome of interest is rectal epithelial cell apoptosis as measured by TUNEL (TdT-mediated dUTP Nick-End Labeling). The TUNEL assay is conducted to measure apoptosis of colon epithelium using DeadEnd Colorimetric TUNEL System (Promega). After all fields of each sample are measured, the final immunoreaction indices are generated automatically by setting algorithms as ''total positive area / total nuclear area. Apoptotic activity is also scored using standard morphologic criteria applied to H\&E stained sections.

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
Rectal Epithelial Cell Apoptosis	1.17 percentage of cells positive Standard Deviation 1.79	1.30 percentage of cells positive Standard Deviation 1.30	1.00 percentage of cells positive Standard Deviation 1.27	2.61 percentage of cells positive Standard Deviation 4.55	1.44 percentage of cells positive Standard Deviation 1.77	1.33 percentage of cells positive Standard Deviation 1.78

SECONDARY outcome

Timeframe: 6 months

Expression of COX-2 in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
Rectal Epithelial Cell COX-2 Expression	6.47 percentage of cells positive Standard Deviation 4.40	4.62 percentage of cells positive Standard Deviation 2.81	5.10 percentage of cells positive Standard Deviation 3.05	5.31 percentage of cells positive Standard Deviation 3.32	2.86 percentage of cells positive Standard Deviation 1.40	5.86 percentage of cells positive Standard Deviation 4.29

SECONDARY outcome

Timeframe: 6 months

Expression of 15-PGDH in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
Rectal Epithelial Cell 15-PGDH Expression	27.5 percentage of cells positive Standard Deviation 8.14	27.6 percentage of cells positive Standard Deviation 4.58	25.1 percentage of cells positive Standard Deviation 6.42	29.3 percentage of cells positive Standard Deviation 6.3	23.8 percentage of cells positive Standard Deviation 8.5	27.1 percentage of cells positive Standard Deviation 6.15

SECONDARY outcome

Timeframe: 6 months

Population: Due to inadequate rectal tissue specimens we were unable to measure rectal tissue phospholipids

Lipids will be extracted using the method of Folch-Lees

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: For some participants the volume of frozen tissue was not enough to measure rectal eicosanoids and are not included in the analysis (2 from GG, fish oil, 2 from GG, placebo, 3 from GT fish oil, 4 GT placebo, 1 TT fish oil and 3 TT placebo)

liquid chromatography/tandem mass spectrometric on rectal biopsy samples

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=19 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=15 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=15 Participants Oleic Acid Oleic Acid: Placebo
Rectal Epithelial Cell Production of PGE2 and PGE3 PGE3	1.40 ng/g Standard Deviation 1.87	2.89 ng/g Standard Deviation 3.38	2.10 ng/g Standard Deviation 2.00	2.63 ng/g Standard Deviation 2.98	4.43 ng/g Standard Deviation 9.04	1.84 ng/g Standard Deviation 2.00
Rectal Epithelial Cell Production of PGE2 and PGE3 PGE2	11.4 ng/g Standard Deviation 13.3	23.6 ng/g Standard Deviation 33.4	14.4 ng/g Standard Deviation 19.7	22.1 ng/g Standard Deviation 40.0	16.6 ng/g Standard Deviation 14.1	24.4 ng/g Standard Deviation 27.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
C-reactive Protein	3.98 mg/L Standard Deviation 6.64	3.87 mg/L Standard Deviation 7.13	2.11 mg/L Standard Deviation 2.23	4.96 mg/L Standard Deviation 6.92	2.58 mg/L Standard Deviation 4.00	2.34 mg/L Standard Deviation 2.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Adipokines were not measured on all trial participants due to assay expense. Samples measurements were not completed on 3 GG, fish oil, 0 GG, placebo, 3 GT fish oil, 4 GT placebo, 7 TT fish oil, 9 TT placebo

leptin and adiponectin

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=21 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=19 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=9 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=9 Participants Oleic Acid Oleic Acid: Placebo
Adipokines Leptin	25.3 ng/mL Standard Deviation 19.0	24.0 ng/mL Standard Deviation 30.1	20.2 ng/mL Standard Deviation 15.7	27.9 ng/mL Standard Deviation 22.0	10.9 ng/mL Standard Deviation 8.62	23.0 ng/mL Standard Deviation 26.4
Adipokines Adiponectin	22.4 ng/mL Standard Deviation 25.8	20.5 ng/mL Standard Deviation 17.9	18.9 ng/mL Standard Deviation 13.4	14.9 ng/mL Standard Deviation 13.9	29.4 ng/mL Standard Deviation 33.9	15.3 ng/mL Standard Deviation 7.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

homeostasis model assessment-insulin resistance (HOMA-IR) HOMA-IR. Fasting insulin and glucose were be used to determine HOMA-IR: \[fasting glucose (mmol/l) x fasting insulin (µU/ml)\]/22.5\]", Optimal insulin sensitivity: \< 1, Early insulin resistance: \> 1.9, Significant insulin resistance: \> 2.9

Outcome measures

Outcome measures
Measure	rs174535 (GG), Fish Oil Supplements n=24 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=20 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=22 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=24 Participants Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=16 Participants Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=18 Participants Oleic Acid Oleic Acid: Placebo
Insulin Sensitivity	0.67 HOMA-IR Index Standard Deviation 0.56	0.98 HOMA-IR Index Standard Deviation 0.92	0.67 HOMA-IR Index Standard Deviation 0.57	1.01 HOMA-IR Index Standard Deviation 1.33	0.72 HOMA-IR Index Standard Deviation 0.75	0.80 HOMA-IR Index Standard Deviation 0.75

Adverse Events

rs174535 (GG), Fish Oil Supplements

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

rs174535 (GG), Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

rs174535 (GT), Fish Oil Supplements

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

rs174535 (GT), Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

rs174535 (TT), Fish Oil Supplement

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

rs174535 (TT), Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rs174535 (GG), Fish Oil Supplements n=26 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=25 participants at risk Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=25 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=26 participants at risk Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=19 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=20 participants at risk Oleic Acid Oleic Acid: Placebo
Cardiac disorders Myocardial Infarction	0.00% 0/26 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	4.0% 1/25 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/25 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/26 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/19 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/20 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.

Other adverse events

Other adverse events
Measure	rs174535 (GG), Fish Oil Supplements n=26 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GG), Placebo n=25 participants at risk Oleic Acid Oleic Acid: Placebo	rs174535 (GT), Fish Oil Supplements n=25 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (GT), Placebo n=26 participants at risk Oleic Acid Oleic Acid: Placebo	rs174535 (TT), Fish Oil Supplement n=19 participants at risk Eicosapentanoic acid and docosahexanoic acid Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks	rs174535 (TT), Placebo n=20 participants at risk Oleic Acid Oleic Acid: Placebo
Gastrointestinal disorders Bloating and eructations	3.8% 1/26 • Number of events 1 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/25 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/25 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	0.00% 0/26 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	10.5% 2/19 • Number of events 2 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.	5.0% 1/20 • Number of events 1 • 6 months For the purposes of this study and adverse event is defined as any untoward medical occurrence in a subject, not necessarily having a causal relationship with the study. A serious adverse event (SAE) is any untoward medical occurrence that a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent or significant disability/incapacity, or e) is a congenital anomaly/birth defect.

Additional Information

Harvey J Murff

Vanderbilt University Medical Center

Phone: 615 936 8319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place