Trial Outcomes & Findings for Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF) (NCT NCT02840799)
NCT ID: NCT02840799
Last Updated: 2023-12-18
Results Overview
Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)
Results posted on
2023-12-18
Participant Flow
Following the endpoint assessment of the first phase, subjects will enter a 1-week washout period during which they will not receive any study medications.
Participant milestones
| Measure |
Potassium Nitrate (KNO3), Then Potassium Chloride (KCl)
Potassium nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks.
After a one week washout period, participants crossed over to take Potassium Chloride.
Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Potassium Chloride (KCl) Then Potassium Nitrate (KNO3)
Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
Potassium Nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks.
After a one week washout period, participants crossed over to take Potassium Nitrate.
|
|---|---|---|
|
Phase 1
STARTED
|
41
|
43
|
|
Phase 1
COMPLETED
|
36
|
40
|
|
Phase 1
NOT COMPLETED
|
5
|
3
|
|
Phase 2 (Crossover)
STARTED
|
41
|
35
|
|
Phase 2 (Crossover)
COMPLETED
|
41
|
33
|
|
Phase 2 (Crossover)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Potassium Nitrate (KNO3), Then Potassium Chloride (KCl)
Potassium nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks.
After a one week washout period, participants crossed over to take Potassium Chloride.
Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Potassium Chloride (KCl) Then Potassium Nitrate (KNO3)
Potassium Chloride (KCl) capsules was administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
Potassium Nitrate (KNO3) capsules, provided 6 millimoles of inorganic nitrate per capsule, and was taken three times daily for 6 weeks.
After a one week washout period, participants crossed over to take Potassium Nitrate.
|
|---|---|---|
|
Phase 1
Physician Decision
|
1
|
3
|
|
Phase 1
Withdrawal by Subject
|
4
|
0
|
|
Phase 2 (Crossover)
Adverse Event
|
0
|
1
|
|
Phase 2 (Crossover)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF)
Baseline characteristics by cohort
| Measure |
Experimental: Potassium Nitrate (KNO3) Then Potassium Chloride (KCl)
n=41 Participants
Participants were randomized and first received potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks. Potassium nitrate is the active drug in this trial.
After a washout period of 1 week, participant crossed over to receive potassium chloride (KCl), the matching placebo (control drug) in this trial. Potassium Chloride (KCl) capsules were administered at a dose of 6 millimoles (1 capsule) three times daily for 6 week.
|
Experimental: Potassium Chloride (KCl) Then Potassium Nitrate (KNO3)
n=43 Participants
Participants were randomized and first received potassium chloride (KCl), the matching placebo (control drug) in this trial. Potassium Chloride (KCl) capsules were administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
After a washout period of 1 week, participants cross over to receive potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
35.3 kg/m2
STANDARD_DEVIATION 7.89 • n=5 Participants
|
37.1 kg/m2
STANDARD_DEVIATION 7.86 • n=7 Participants
|
36.2 kg/m2
STANDARD_DEVIATION 7.88 • n=5 Participants
|
|
Current Smoker
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Current Smoker
No
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Former smoker
Yes
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Former smoker
No
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Prior Acute Coronary Syndrome or Myocardial infarction
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior Angina
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Prior Arrythmia
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Prior significant valvular disease or valve surgery in the past
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hypertension
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
High Cholesterol
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Peripheral vascular disease
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Diabetes
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Prior CVA/TIA
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior Pulmonary embolism/DVT
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Obstructive sleep apnea (OSA)
Obstructive sleep apnea (OSA)
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Obstructive sleep apnea (OSA)
CPAP Use
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
COPD/Asthma
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Prior CABG
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Osteoarthritis
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
NYHA Class
I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
NYHA Class
II
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
NYHA Class
III
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
NYHA Class
IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
130 mmHg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
133 mmHg
STANDARD_DEVIATION 17.4 • n=7 Participants
|
132 mmHg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Diastolic Pressure
|
74.7 mmHg
STANDARD_DEVIATION 8.97 • n=5 Participants
|
74.7 mmHg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
74.7 mmHg
STANDARD_DEVIATION 9.58 • n=5 Participants
|
|
Blood Oxygen Saturation
|
97.4 percent (%) oxygen saturation
STANDARD_DEVIATION 1.23 • n=5 Participants
|
97.5 percent (%) oxygen saturation
STANDARD_DEVIATION 1.40 • n=7 Participants
|
97.5 percent (%) oxygen saturation
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
6 Minute Walk Test: Total Meters Walk
|
338 meters
STANDARD_DEVIATION 102 • n=5 Participants
|
333 meters
STANDARD_DEVIATION 94.2 • n=7 Participants
|
336 meters
STANDARD_DEVIATION 97.3 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Physical Limitations Score
|
67.3 scores on a scale of 0-100
STANDARD_DEVIATION 16.2 • n=5 Participants
|
62.0 scores on a scale of 0-100
STANDARD_DEVIATION 22.7 • n=7 Participants
|
64.6 scores on a scale of 0-100
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Symptom Stability Score
|
50.6 scores on a scale of 0-100
STANDARD_DEVIATION 14.2 • n=5 Participants
|
52.3 scores on a scale of 0-100
STANDARD_DEVIATION 17.1 • n=7 Participants
|
51.5 scores on a scale of 0-100
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Symptom Frequency Score
|
69.0 scores on a scale of 0-100
STANDARD_DEVIATION 21.3 • n=5 Participants
|
62.2 scores on a scale of 0-100
STANDARD_DEVIATION 24.2 • n=7 Participants
|
65.5 scores on a scale of 0-100
STANDARD_DEVIATION 22.9 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Sympton Burden Score
|
69.7 scores on a scale of 0-100
STANDARD_DEVIATION 20.4 • n=5 Participants
|
63.6 scores on a scale of 0-100
STANDARD_DEVIATION 21.4 • n=7 Participants
|
66.6 scores on a scale of 0-100
STANDARD_DEVIATION 21 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Total Symptom Score
|
69.3 scores on a scale of 0-100
STANDARD_DEVIATION 19.6 • n=5 Participants
|
62.9 scores on a scale of 0-100
STANDARD_DEVIATION 21 • n=7 Participants
|
66 scores on a scale of 0-100
STANDARD_DEVIATION 20.5 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Self-efficacy Score
|
80.2 scores on a scale of 0-100
STANDARD_DEVIATION 22 • n=5 Participants
|
76.5 scores on a scale of 0-100
STANDARD_DEVIATION 30.3 • n=7 Participants
|
78.3 scores on a scale of 0-100
STANDARD_DEVIATION 26.5 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Quality of Life Score
|
65.0 scores on a scale of 0-100
STANDARD_DEVIATION 22.1 • n=5 Participants
|
56.8 scores on a scale of 0-100
STANDARD_DEVIATION 25.8 • n=7 Participants
|
60.8 scores on a scale of 0-100
STANDARD_DEVIATION 24.3 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Social Limitation Summary Score
|
57.9 scores on a scale of 0-100
STANDARD_DEVIATION 27.5 • n=5 Participants
|
52.7 scores on a scale of 0-100
STANDARD_DEVIATION 23.1 • n=7 Participants
|
55.3 scores on a scale of 0-100
STANDARD_DEVIATION 25.4 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Overall Score
|
64.9 scores on a scale of 0-100
STANDARD_DEVIATION 14.9 • n=5 Participants
|
58.1 scores on a scale of 0-100
STANDARD_DEVIATION 18.4 • n=7 Participants
|
61.4 scores on a scale of 0-100
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Results
Clinical Summary Score
|
68.3 scores on a scale of 0-100
STANDARD_DEVIATION 14 • n=5 Participants
|
62.4 scores on a scale of 0-100
STANDARD_DEVIATION 18.5 • n=7 Participants
|
65.3 scores on a scale of 0-100
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Current Medications
ACE Inhibitors
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Current Medications
Angiotensin Receptor Blockers (ARB)
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Current Medications
Calcium Channel Blockers (CCB)
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Current Medications
Beta Blockers
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Current Medications
Diuretics
|
39 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Current Medications
Statins
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Current Medications
Anti Arrythmia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Current Medications
Anti Coagulation
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current Medications
Anti Platelet
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Current Medications
Insulin
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
eGFR
|
66.4 mL/min/1.73m^2
STANDARD_DEVIATION 16.6 • n=5 Participants
|
70.6 mL/min/1.73m^2
STANDARD_DEVIATION 18.7 • n=7 Participants
|
68.5 mL/min/1.73m^2
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Methemeglobin
|
0.729 Percent in blood
STANDARD_DEVIATION 0.593 • n=5 Participants
|
0.642 Percent in blood
STANDARD_DEVIATION 0.379 • n=7 Participants
|
0.685 Percent in blood
STANDARD_DEVIATION 0.494 • n=5 Participants
|
|
Oxyhemoglobin
|
78.5 Percent in blood
STANDARD_DEVIATION 12.9 • n=5 Participants
|
77.4 Percent in blood
STANDARD_DEVIATION 16.7 • n=7 Participants
|
77.9 Percent in blood
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Carboxyhemoglobin
|
1.82 Percent in blood
STANDARD_DEVIATION 0.3777 • n=5 Participants
|
1.67 Percent in blood
STANDARD_DEVIATION 0.354 • n=7 Participants
|
1.75 Percent in blood
STANDARD_DEVIATION 0.370 • n=5 Participants
|
|
O2 Count
|
14.5 mL/dL
STANDARD_DEVIATION 2.64 • n=5 Participants
|
15.1 mL/dL
STANDARD_DEVIATION 3.96 • n=7 Participants
|
14.8 mL/dL
STANDARD_DEVIATION 3.36 • n=5 Participants
|
|
Hemoglobin
|
13.2 g/dL
STANDARD_DEVIATION 1.42 • n=5 Participants
|
13.4 g/dL
STANDARD_DEVIATION 1.15 • n=7 Participants
|
13.3 g/dL
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
NT Pro-BNP
|
263 pg/mL
STANDARD_DEVIATION 332 • n=5 Participants
|
213 pg/mL
STANDARD_DEVIATION 359 • n=7 Participants
|
238 pg/mL
STANDARD_DEVIATION 344 • n=5 Participants
|
|
Ejection Fraction
|
61.8 Percent total blood
STANDARD_DEVIATION 3.92 • n=5 Participants
|
61.2 Percent total blood
STANDARD_DEVIATION 3.57 • n=7 Participants
|
61.5 Percent total blood
STANDARD_DEVIATION 3.74 • n=5 Participants
|
|
Left Atrial Volume Index
|
28.4 mL/m^2
STANDARD_DEVIATION 9.45 • n=5 Participants
|
26.5 mL/m^2
STANDARD_DEVIATION 8.40 • n=7 Participants
|
27.4 mL/m^2
STANDARD_DEVIATION 8.93 • n=5 Participants
|
|
Septal E/e' Ratio
|
14 Ratio
STANDARD_DEVIATION 5.79 • n=5 Participants
|
13.3 Ratio
STANDARD_DEVIATION 5.39 • n=7 Participants
|
13.6 Ratio
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Lateral E/e' Ratio
|
10.1 Ratio
STANDARD_DEVIATION 3.50 • n=5 Participants
|
11.3 Ratio
STANDARD_DEVIATION 5.34 • n=7 Participants
|
10.7 Ratio
STANDARD_DEVIATION 4.55 • n=5 Participants
|
|
Septal Lateral Mean E/e' Ratio
|
11.5 Ratio
STANDARD_DEVIATION 4.07 • n=5 Participants
|
12.1 Ratio
STANDARD_DEVIATION 4.90 • n=7 Participants
|
11.8 Ratio
STANDARD_DEVIATION 4.49 • n=5 Participants
|
|
White Blood Cells
|
6.68 THO/uL
STANDARD_DEVIATION 2.01 • n=5 Participants
|
7.41 THO/uL
STANDARD_DEVIATION 1.53 • n=7 Participants
|
7.06 THO/uL
STANDARD_DEVIATION 1.81 • n=5 Participants
|
|
Red Blood Cells
|
4.52 MIL/uL
STANDARD_DEVIATION 0.525 • n=5 Participants
|
4.56 MIL/uL
STANDARD_DEVIATION 0.383 • n=7 Participants
|
4.54 MIL/uL
STANDARD_DEVIATION 0.455 • n=5 Participants
|
|
Hematocrit
|
39.8 Percent of blood
STANDARD_DEVIATION 4.23 • n=5 Participants
|
40.5 Percent of blood
STANDARD_DEVIATION 2.98 • n=7 Participants
|
40.1 Percent of blood
STANDARD_DEVIATION 3.63 • n=5 Participants
|
|
RDW (red blood cell distribution width)
|
14.3 Percent red blood cells
STANDARD_DEVIATION 1.51 • n=5 Participants
|
14.4 Percent red blood cells
STANDARD_DEVIATION 1.31 • n=7 Participants
|
14.3 Percent red blood cells
STANDARD_DEVIATION 1.40 • n=5 Participants
|
|
MCH (mean corpuscular hemoglobin)
|
29.4 pg
STANDARD_DEVIATION 2.74 • n=5 Participants
|
19.3 pg
STANDARD_DEVIATION 2.00 • n=7 Participants
|
19.4 pg
STANDARD_DEVIATION 2.37 • n=5 Participants
|
|
MCHC (mean corpuscular hemoglobin concentration)
|
33.1 g/dL
STANDARD_DEVIATION 0.952 • n=5 Participants
|
33.1 g/dL
STANDARD_DEVIATION 0.930 • n=7 Participants
|
33.1 g/dL
STANDARD_DEVIATION 0.935 • n=5 Participants
|
|
MCV (mean corpuscular volume)
|
88.6 fL
STANDARD_DEVIATION 7.40 • n=5 Participants
|
88.8 fL
STANDARD_DEVIATION 5.06 • n=7 Participants
|
88.7 fL
STANDARD_DEVIATION 6.26 • n=5 Participants
|
|
Platelets
|
135 THO/uL
STANDARD_DEVIATION 69.1 • n=5 Participants
|
247 THO/uL
STANDARD_DEVIATION 63.7 • n=7 Participants
|
241 THO/uL
STANDARD_DEVIATION 66.2 • n=5 Participants
|
|
Glucose
|
108 mg/dL
STANDARD_DEVIATION 30.9 • n=5 Participants
|
112 mg/dL
STANDARD_DEVIATION 49.6 • n=7 Participants
|
110 mg/dL
STANDARD_DEVIATION 41.3 • n=5 Participants
|
|
Urea Nitrogen
|
20.6 mg/dL
STANDARD_DEVIATION 7.76 • n=5 Participants
|
10.0 mg/dL
STANDARD_DEVIATION 7.20 • n=7 Participants
|
20.3 mg/dL
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Creatinine
|
1.01 mg/dL
STANDARD_DEVIATION 0.230 • n=5 Participants
|
1.00 mg/dL
STANDARD_DEVIATION 0.290 • n=7 Participants
|
1.01 mg/dL
STANDARD_DEVIATION 0.261 • n=5 Participants
|
|
Sodium
|
139 mmol/L
STANDARD_DEVIATION 2.58 • n=5 Participants
|
129 mmol/L
STANDARD_DEVIATION 2.07 • n=7 Participants
|
129 mmol/L
STANDARD_DEVIATION 2.32 • n=5 Participants
|
|
Potassium
|
4.17 mmol/L
STANDARD_DEVIATION 0.435 • n=5 Participants
|
4.17 mmol/L
STANDARD_DEVIATION 0.391 • n=7 Participants
|
4.17 mmol/L
STANDARD_DEVIATION 0.411 • n=5 Participants
|
|
Chloride
|
101 mmol/L
STANDARD_DEVIATION 2.59 • n=5 Participants
|
101 mmol/L
STANDARD_DEVIATION 3.15 • n=7 Participants
|
101 mmol/L
STANDARD_DEVIATION 2.88 • n=5 Participants
|
|
Carbon dioxide
|
28.5 mmol/L
STANDARD_DEVIATION 2.84 • n=5 Participants
|
28.7 mmol/L
STANDARD_DEVIATION 3.02 • n=7 Participants
|
28.6 mmol/L
STANDARD_DEVIATION 2.91 • n=5 Participants
|
|
Anion gap
|
8.76 mmol/L
STANDARD_DEVIATION 1.39 • n=5 Participants
|
8.59 mmol/L
STANDARD_DEVIATION 2.24 • n=7 Participants
|
8.67 mmol/L
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Calcium
|
9.67 mg/dL
STANDARD_DEVIATION 0.398 • n=5 Participants
|
9.65 mg/dL
STANDARD_DEVIATION 0.435 • n=7 Participants
|
9.66 mg/dL
STANDARD_DEVIATION 0.415 • n=5 Participants
|
|
Protein, total
|
7.13 g/dL
STANDARD_DEVIATION 0.590 • n=5 Participants
|
7.07 g/dL
STANDARD_DEVIATION 0.501 • n=7 Participants
|
7.10 g/dL
STANDARD_DEVIATION 0.544 • n=5 Participants
|
|
Albumin, total
|
4.30 g/dL
STANDARD_DEVIATION 0.291 • n=5 Participants
|
4.24 g/dL
STANDARD_DEVIATION 0.339 • n=7 Participants
|
4.27 g/dL
STANDARD_DEVIATION 0.319 • n=5 Participants
|
|
Bilirubin, total
|
0.590 mg/dL
STANDARD_DEVIATION 0.241 • n=5 Participants
|
0.564 mg/dL
STANDARD_DEVIATION 0.195 • n=7 Participants
|
0.577 mg/dL
STANDARD_DEVIATION 0.218 • n=5 Participants
|
|
Alkaline phophatase
|
78.5 U/L
STANDARD_DEVIATION 36.4 • n=5 Participants
|
72.3 U/L
STANDARD_DEVIATION 19.4 • n=7 Participants
|
75.3 U/L
STANDARD_DEVIATION 29.0 • n=5 Participants
|
|
AST (aspartate transferase)
|
20.5 U/L
STANDARD_DEVIATION 7.93 • n=5 Participants
|
24.0 U/L
STANDARD_DEVIATION 11.5 • n=7 Participants
|
22.3 U/L
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
ALT (alanine transaminase)
|
19.0 U/L
STANDARD_DEVIATION 8.24 • n=5 Participants
|
22.2 U/L
STANDARD_DEVIATION 13.4 • n=7 Participants
|
20.6 U/L
STANDARD_DEVIATION 11.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: As this is a crossover trial, participants received both KNO3 and KCl in different phase, and the sequence of which was dependent on a double blinded randomization. Only participants with outcome data were analyzed. The mean, SD, and t-tests were calculated based on the number of completed cases with successful crossover (N=60), but the mixed model included phase 1 data as well (N=74).
Subjects will perform a maximal-effort peak oxygen consumption test using a supine bicycle exercise test with expired gas analysis.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=65 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=67 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
Prior to randomization
|
|---|---|---|---|
|
Difference in Peak Oxygen Consumption (Vo2) Between KNO3 and KCl Phases
|
10.31714 L/min/kg
Standard Deviation 3.851249
|
10.215172 L/min/kg
Standard Deviation 3.823188
|
—
|
PRIMARY outcome
Timeframe: 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: Total work was calculated at each phase of the crossover trial. However, the analysis for the t-tests including the reported mean and standard deviation only includes cases in which Phase 1 and Phase 2 were completed.
Subjects will perform a maximal-effort supine bicycle exercise test.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=68 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=69 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
Prior to randomization
|
|---|---|---|---|
|
Change in Total Work Performed During a Maximal-effort Exercise Test From Phase 1 to Phase 2
|
26.74341 KJ
Standard Deviation 32.15162
|
23.76294 KJ
Standard Deviation 29.88680
|
—
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: As this is a crossover trial, participants received both KNO3 and KCl in different phases, the sequence of which was dependent on a double blinded randomization. Only participants with KCCQ results were analyzed. The mean, SD, and t-tests were calculated based on the number of completed cases with successful crossover (N=66), but the mixed model included phase 1 data as well. Baseline scores for all participants were analyzed in the mixed model as a predictive value.
QOL will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ). The overall summary score from the KCCQ ranges from 0-100, where higher scores indicate a better quality of life.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=71 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=71 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=84 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Quality of Life (QOL)
|
66.06147 score on a scale
Standard Deviation 18.99883
|
62.77142 score on a scale
Standard Deviation 18.95087
|
61.4335 score on a scale
Standard Deviation 17.02081
|
SECONDARY outcome
Timeframe: 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)We measured the Systematic vasodilatory response at rest and peak maximal exercise using corresponding echo parameters and blood pressures for each visit. This measure depicts the change from rest and exercise.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=54 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=58 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
Prior to randomization
|
|---|---|---|---|
|
Effect of KNO3 on the Percent Change of Systemic Vasodilatory Response to Exercise: The Change in Systemic Vascular Resistance Reserve During Exercise During a Maximal Effort Exercise Test
|
-23.92288 % change
Standard Deviation 23.39527
|
-22.13564 % change
Standard Deviation 24.67150
|
—
|
SECONDARY outcome
Timeframe: 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: MRI was not completed throughout the duration of the study and only completed at one site (University of Pennsylvania).
Muscle PCr recovery kinetics were measured using MRI and a standardized plantar flexor exercise protocol with a high resolution spatial mapping of creatine in muscle to analyze creatine chemical exchange saturation transfer and quantify the recovery kinetics of creatine levels. Exercise induces increases in the rate of O2 consumption, which upon cessation of exercise, declines towards baseline in a mono-exponential fashion. This is characterized by a time constant (τ, tau) that corresponds to the time constant of PCr recovery kinetics. Muscle PCr is a marker of oxidative capacity. This outcome measure relates to the half-time derived from linear regression, where a lower value depicts a faster PCr recovery.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=15 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=15 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Muscle Phosphocreatine (PCr) Recovery Kinetics Following a Standardized Plantar Flexor Exercise Protocol
|
159.5455 seconds
Standard Deviation 99.54442
|
219.8485 seconds
Standard Deviation 149.41312
|
—
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: All participants were expected to undergo an echocardiogram at each visit (baseline, Phase 1, and Phase 2).
E/e' ratio is a standard echo parameter that was measured at rest during each visit and calculated using the mitral E, septal e', and lateral e'. This index is parameter for noninvasive left ventricular diastolic function assessment, where an E/e' ratio \< 8 is considered to be normal, and a ratio \> 15 is considered to reflect an increase in the LV filling pressure.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=67 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=68 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=81 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: E/e' Ratio
|
11.84599 Ratio
Standard Deviation 3.981865
|
11.61516 Ratio
Standard Deviation 4.265457
|
11.7999 Ratio
Standard Deviation 4.48822
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Left atrial volume index is a standard echo parameter that was measured at rest during each visit and calculated the body surface area (Dubois and Dubois equation) and left atrial volume from both the two chamber and four chamber views.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=69 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=68 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=84 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Left Ventricle (LV) Diastolic Function: Left Atrial Volume Index
|
26.63060 mL/m2
Standard Deviation 7.812431
|
27.65687 mL/m2
Standard Deviation 9.931385
|
27.4408 mL/m2
Standard Deviation 8.92840
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: All participants underwent an echocardiogram at each visit; however, participants in which these echo measures could not be reliably quantified were excluded.
Peak global systolic myocardial longitudinal strain was evaluated with resting echocardiograms at each visit. Strain was analyzed at the four chamber, two chamber, and three chamber views of the left ventricle and averaged.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=61 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=61 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=69 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Myocardial Systolic Strain: Peak Global Systolic Myocardial Longitudinal Strain
|
18.04317 % (change in length)
Standard Deviation 2.812165
|
17.273221 % (change in length)
Standard Deviation 3.003472
|
17.7164 % (change in length)
Standard Deviation 2.289224
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Late systolic wall stress is assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. Myocardial wall stress was calculated with the following formula =: Stress = P / \[1/3 In (1 + VW/VLV)\], where ln is the natural logarithm, P is aortic pressure obtained with arterial tonometry, VW is the volume of the LV wall obtained with echocardiography and VLV is the cavity volume obtained with echocardiography
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=55 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=57 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=70 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Late Systolic Wall Stress as Assessed by the Arts Formula Using Echocardiographic and Tonometry Recordings
|
32.36347 dynes·cm-2·s
Standard Deviation 7.464010
|
34.31358 dynes·cm-2·s
Standard Deviation 7.837627
|
33.95494 dynes·cm-2·s
Standard Deviation 7.746475
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Arterial Wave reflections were assessed via wave separation analysis, using arterial tonometry and Doppler echocardiography. The pulse wave generated by the left ventricle travels forward in arteries and is partially reflected at sites of impedance mismatch (i.e., bifurcations, points of change in arterial size or wall stiffness, predominantly in middle-sized conduit arteries). Wave reflections travel back to the heart, merging into a discrete reflected wave and arrive while the LV is still ejecting blood in mid-to-late systole. Wave reflections increase the late systolic workload of the LV and profoundly impact the LV loading sequence (late relative to early systolic load).
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=55 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=57 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=70 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Arterial Wave Reflections as Assessed by Wave Separation Analysis Using Tonometry and Doppler Flow Data
|
0.3681837 unitless
Standard Deviation 0.08317293
|
0.372307 unitless
Standard Deviation 0.0786807
|
0.3804 unitless
Standard Deviation 0.07106
|
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Aortic augmentation index was assessed via comprehensive aortic pressure-flow relations, using arterial tonometry and Doppler echocardiography. It is an indirect measure of arterial stiffness, where a higher value would indicate greater arterial stiffness risk.
Outcome measures
| Measure |
Potassium Nitrate (KNO3)
n=55 Participants
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=57 Participants
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline
n=70 Participants
Prior to randomization
|
|---|---|---|---|
|
Effect of Potassium Nitrate (KNO3) on Augmentation Index
|
122.6139 Index
Standard Deviation 25.40388
|
122.5160 Index
Standard Deviation 28.58736
|
126.3574 Index
Standard Deviation 26.08744
|
SECONDARY outcome
Timeframe: 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: Analysis could not be performed as the MRI studies were not able to extract this measure.
MRI studies will be performed at rest and immediately after a standardized plantar flexion exercise. Arterial spin labeling using the flow-sensitive alternating inversion recovery (FAIR) technique will be used to image muscle perfusion with high temporal resolution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: All three visits: Baseline (first) visit; 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)Population: Peak Global Systolic Myocardial Circumferential Strain was not analyzed in the echocardiogram as this measure was not quantified at all during the study; instead, other strain measurements were evaluated alternatively that are considered to be more reliable.
Outcome measures
Outcome data not reported
Adverse Events
Potassium Nitrate (KNO3)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Potassium Chloride (KCl)
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Baseline Visit
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Potassium Nitrate (KNO3)
n=77 participants at risk
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=74 participants at risk
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline Visit
n=84 participants at risk
At the baseline visit, patients were not on IP, but participants were monitored and consented in the study.
All participants were at risk during their baseline visit, even the screen fails.
Events include events that occurred in participants who were not randomized as well as those who were randomized.
|
|---|---|---|---|
|
Cardiac disorders
rapid heart beat
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
abnormal sensation of swallowing
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
aches in the joints
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
acute exacerbation of bronchiectasis
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
belching
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
bilateral knee pain
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Eye disorders
blurred vision
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
calves aching
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
cramps
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Renal and urinary disorders
creatinine increase
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
dizziness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
edema
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
fatigue
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Immune system disorders
fever
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Infections and infestations
flu
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
gassiness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
headache
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Endocrine disorders
hypoglycemic episode
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
increased stomach acid
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
insomnia
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
leg cramps
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
nasal discharge
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Psychiatric disorders
nervousness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
o2 desaturation
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Infections and infestations
oral thrush
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Cardiac disorders
palpitations
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
positive orthostat
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
restlessness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath during the peak exercise test
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
soreness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
spasms
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
stomach ache
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
swelling
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
thigh cramps
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
weakness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
fatigue during the peak exercise test
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
other
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
Other adverse events
| Measure |
Potassium Nitrate (KNO3)
n=77 participants at risk
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Potassium Nitrate (KNO3): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
|
Potassium Chloride (KCl)
n=74 participants at risk
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Potassium Chloride (KCl): Potassium Chloride (KCl) is the matching placebo control drug in this trial.
|
Baseline Visit
n=84 participants at risk
At the baseline visit, patients were not on IP, but participants were monitored and consented in the study.
All participants were at risk during their baseline visit, even the screen fails.
Events include events that occurred in participants who were not randomized as well as those who were randomized.
|
|---|---|---|---|
|
Gastrointestinal disorders
abnormal sensation of swallowing
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
aches in the joints
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
acute exacerbation of bronchiectasis
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
belching
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
bilateral knee pain
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Eye disorders
blurred vision
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
calves aching
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
3.9%
3/77 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
5.4%
4/74 • Number of events 4 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
cramps
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Renal and urinary disorders
creatinine increase
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
diarrhea
|
2.6%
2/77 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
4.1%
3/74 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
3.6%
3/84 • Number of events 4 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
dizziness
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.7%
2/74 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
edema
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
fatigue
|
14.3%
11/77 • Number of events 12 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
5.4%
4/74 • Number of events 6 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
7.1%
6/84 • Number of events 6 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Immune system disorders
fever
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Infections and infestations
flu
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
gassiness
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
4.1%
3/74 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
headache
|
10.4%
8/77 • Number of events 8 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
5.4%
4/74 • Number of events 5 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Endocrine disorders
hypoglycemic episode
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
increased stomach acid
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
insomnia
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
leg cramps
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
lightheadedness
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.7%
2/74 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
nasal discharge
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
nausea
|
7.8%
6/77 • Number of events 6 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
5.4%
4/74 • Number of events 4 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
6.0%
5/84 • Number of events 5 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Psychiatric disorders
nervousness
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
o2 desaturation
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Infections and infestations
oral thrush
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Cardiac disorders
palpitations
|
3.9%
3/77 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
positive orthostat
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Cardiac disorders
rapid heart beat
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Nervous system disorders
restlessness
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
9.1%
7/77 • Number of events 8 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
8.1%
6/74 • Number of events 6 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath during the peak exercise test
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
4.1%
3/74 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
6.8%
5/74 • Number of events 5 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
soreness
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
spasms
|
0.00%
0/77 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
stomach ache
|
19.5%
15/77 • Number of events 18 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
9.5%
7/74 • Number of events 8 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
8.3%
7/84 • Number of events 7 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Skin and subcutaneous tissue disorders
swelling
|
6.5%
5/77 • Number of events 5 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
4.1%
3/74 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
thigh cramps
|
1.3%
1/77 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Gastrointestinal disorders
vomiting
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
1.4%
1/74 • Number of events 1 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
3.6%
3/84 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
Musculoskeletal and connective tissue disorders
weakness
|
3.9%
3/77 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/74 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
fatigue during the peak exercise test
|
2.6%
2/77 • Number of events 2 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
4.1%
3/74 • Number of events 3 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
0.00%
0/84 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
|
General disorders
other
|
20.8%
16/77 • Number of events 29 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
23.0%
17/74 • Number of events 22 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
14.3%
12/84 • Number of events 19 • Adverse events were collected for each participant starting on their baseline visit to 6 weeks per intervention with 1 week wash-out between, up to 13 weeks
Total number at risk for baseline column is total number of participants at risk during the baseline visit including participants who screen failed (screen fail participants still attended a baseline visit). These events happened prior to randomization. Total number at risk for either KCl or KNO3 refers to the total number of participants randomized to medication or placebo respectively at risk for an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place