Trial Outcomes & Findings for Dietary Acid Load, Kidney Function and Disability in Elderly (NCT NCT02691663)
NCT ID: NCT02691663
Last Updated: 2023-09-25
Results Overview
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
COMPLETED
NA
196 participants
baseline
2023-09-25
Participant Flow
196 subjects signed consent; all except 83 were screen failures; 83 subjects were randomized
Participant milestones
| Measure |
Oral Bicarbonate Supplementation Group
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Oral Bicarbonate Supplementation Group
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Overall Study
Screen failure after baseline
|
2
|
2
|
|
Overall Study
withdrawn after Follow up 1 visit
|
2
|
2
|
|
Overall Study
Withdrawn after Follow up 2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Dietary Acid Load, Kidney Function and Disability in Elderly
Baseline characteristics by cohort
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
72.3 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
72.8 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: PI is reporting blood bicarbonate from blood gas measurement as a surrogate of NEA because a percentage of NEA samples could not be accurately measured due to technical issues.
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Blood Bicarbonate
|
22.8 mmol/L
Standard Deviation 2.3
|
23.2 mmol/L
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: six months post baselinePopulation: PI is reporting blood bicarbonate from blood gas measurement as a surrogate of NEA because a percentage of NEA samples could not be accurately measured due to technical issues.
measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Blood Bicarbonate
|
23.8 mmol/L
Standard Deviation 2.3
|
23.3 mmol/L
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: baselineThe number of participants randomized divided by the number of participants screened. Count of participants reflects the number of participants randomized.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=196 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Percentage of Screened Participants Randomized
|
83 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months post baselinebased on pill count
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=34 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=37 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Percent Adherence: Percentage of Pills Taken
|
90.5 percentage of pills
Standard Deviation 12.9
|
85.2 percentage of pills
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: baselineBlood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Carbon Dioxide Blood Test
|
35.4 mEq/L
Standard Deviation 3.6
|
36.5 mEq/L
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: six months post baselineBlood test that measures the total dissolved Carbon dioxide in blood; expressed in milliequivalents per liter (mEq/L)
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Carbon Dioxide Blood Test
|
36.9 mEq/L
Standard Deviation 3.9
|
37.0 mEq/L
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
400 Meter Walk Time
|
6.3 minutes
Standard Deviation 1.2
|
6.3 minutes
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: three months post baselinePopulation: 1 bicarb Participant refused 400m walk at the 3-month visit.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=37 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
400 Meter Walk Time
|
6.3 minutes
Standard Deviation 1.0
|
6.5 minutes
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: 3 participants (2 bicarb and 1 placebo) refused 400m walk at the 6-month visit
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=31 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=34 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
400 Meter Walk Time
|
6.1 minutes
Standard Deviation 1.0
|
6.3 minutes
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: baselinePopulation: creatinine and MDRD equation
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
|
65.4 mL/min/1.73m^2
Standard Deviation 13.1
|
66.9 mL/min/1.73m^2
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: three months post baselinea measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=34 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=37 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
|
66 mL/min/1.73m^2
Standard Deviation 15.3
|
63.9 mL/min/1.73m^2
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: creatinine and MDRD equation
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
|
64.7 mL/min/1.73m^2
Standard Deviation 16.0
|
64.7 mL/min/1.73m^2
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: baselinePopulation: cystatin C and CKD Epi equation
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=41 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Measurement of Kidney Function (eGFR) at Baseline.
|
81.3 mL/min/1.73m^2
Standard Deviation 19.1
|
81.3 mL/min/1.73m^2
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: cystatin C and CKD Epi equation
a measurement from a blood sample; shows how well kidneys are working According to the National Institutes of Health (NIH), normal results range from 60 to 120 mL/min/1.73 m2. Older people will have lower than normal eGFR levels, because eGFR decreases with age
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) - Measurement of Kidney Function After 6 Months Post Baseline
|
80.1 mL/min/1.73m^2
Standard Deviation 20.3
|
81.0 mL/min/1.73m^2
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: baselinePopulation: No baseline dual energy x-ray absorptiometry (DXA) scans were completed for 3 bicarb and 1 placebo participants.
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=38 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=41 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Hip Bone Mineral Density
|
.94 g/cm^3
Standard Deviation .15
|
.93 g/cm^3
Standard Deviation .18
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants.
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=32 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=32 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Hip Bone Mineral Density
|
.93 g/cm^3
Standard Deviation .15
|
.91 g/cm^3
Standard Deviation .15
|
SECONDARY outcome
Timeframe: baselinePopulation: No baseline DXA scans were completed for 3 bicarb and 1 placebo participants.
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=38 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=41 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Femoral Neck Bone Mineral Density
|
.76 g/cm^3
Standard Deviation .13
|
.74 g/cm^3
Standard Deviation .15
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: No 6-month DXA scans were completed for 1 bicarb and 3 placebo participants.
Bone Mineral Density tests can identify osteoporosis, determine the risk for fractures (broken bones), and measure the response to osteoporosis treatment.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=32 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=32 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Femoral Neck Bone Mineral Density
|
.74 g/cm^3
Standard Deviation .13
|
.72 g/cm^3
Standard Deviation .14
|
SECONDARY outcome
Timeframe: baselinePopulation: baseline BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=38 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=41 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Average Body Mass Index (BMI)
|
27.6 kg/m^2
Standard Deviation 5.3
|
28.1 kg/m^2
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: three months post baselinePopulation: 3-month BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=31 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=36 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Average Body Mass Index (BMI)
|
26.6 kg/m^2
Standard Deviation 4.4
|
28.3 kg/m^2
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: 6-month BMI is missing for 4 participants (3 bicarb and 1 placebo) due to missing height measurement (height was only measured at the screening visit).
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=30 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=34 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Average Body Mass Index (BMI)
|
26.3 kg/m^2
Standard Deviation 4.4
|
28.1 kg/m^2
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: baselinePopulation: baseline ACR is missing for 7 participants (3 bicarb and 4 placebo).
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=38 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=38 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (ACR)
|
25.1 mg/g
Standard Deviation 23.2
|
53.8 mg/g
Standard Deviation 139.7
|
SECONDARY outcome
Timeframe: three months post baselinePopulation: 3-month ACR is missing for 10 participants (5 bicarb and 5 placebo).
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=29 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=32 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (ACR)
|
33.9 mg/g
Standard Deviation 40.3
|
52.8 mg/g
Standard Deviation 126.0
|
SECONDARY outcome
Timeframe: six months post baselinePopulation: 6-month ACR is missing for 5 participants (0 bicarb and 5 placebo).
The albumin-to-creatinine ratio (ACR) is the first method of preference to detect elevated protein, measuring urinary ACR in a spot urine sample. ACR is calculated by dividing albumin concentration in milligrams by creatinine concentration in grams.
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=30 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Urinary Albumin to Creatinine Ratio (ACR)
|
45.1 mg/g
Standard Deviation 119.8
|
80.4 mg/g
Standard Deviation 254.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post randomizationPopulation: 6 month data missing for one subject in bicarbonate (bicarb) arm
(mEq/day) by the kidney
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=32 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Net Endogenous Acid Production (NEAP)
|
75.0 mEq/day
Standard Deviation 37.6
|
73.8 mEq/day
Standard Deviation 39.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post randomizationmEq/day by the kidney
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=34 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=37 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Net Endogenous Acid Production (NEAP)
|
79.4 mEq/day
Standard Deviation 33.2
|
75.3 mEq/day
Standard Deviation 38.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinemEq/day by the kidney
Outcome measures
| Measure |
Oral Bicarbonate Supplementation Group
n=33 Participants
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=35 Participants
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Net Endogenous Acid Production (NEAP)
|
79.3 mEq/day
Standard Deviation 29.7
|
72.1 mEq/day
Standard Deviation 23.4
|
Adverse Events
Oral Bicarbonate Supplementation Group
Placebo Group
Serious adverse events
| Measure |
Oral Bicarbonate Supplementation Group
n=41 participants at risk
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 participants at risk
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
0.00%
0/42 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/41 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
Other adverse events
| Measure |
Oral Bicarbonate Supplementation Group
n=41 participants at risk
0.3 meq/kg/day NaHCO3 capsules
Oral bicarbonate supplementation
|
Placebo Group
n=42 participants at risk
Methylcellulose capsules
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
indigestion
|
2.4%
1/41 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
4.8%
2/42 • Number of events 2 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/41 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • Number of events 2 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
0.00%
0/42 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
0.00%
0/42 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Cardiac disorders
edema
|
4.9%
2/41 • Number of events 2 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/41 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Gastrointestinal disorders
diarrhea
|
2.4%
1/41 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
2.4%
1/41 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
0.00%
0/42 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
|
Injury, poisoning and procedural complications
Broken fifth toe right side
|
0.00%
0/41 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected after subjects signed consent until the end of subject participation over a period of 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place