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Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04622709
Enrollment
39
Registered
2020-11-10
Start date
2020-10-07
Completion date
2021-06-22
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Hemodialysis, Dialysis, End Stage Renal Disease, Patient-reported Outcomes, Symptoms, Diuretic, Furosemide, Lasix

Brief summary

Individuals with kidney failure receiving maintenance hemodialysis (HD) have high mortality rates, driven largely by cardiovascular causes. Volume-related factors are critical, modifiable contributors to cardiovascular complications. Reversing volume overload has been shown to improve blood pressure and cardiac remodeling. Use of loop diuretics may represent a pragmatic, low-cost, and low-burden strategy to improve outcomes in people receiving HD. Lack of data on optimal furosemide dosing, safety, and acceptability are barriers to expanded use. This study investigates whether oral furosemide is safe and effective at increasing urine volume in HD patients.

Interventions

DRUGFurosemide (loop diuretic) Tablets

Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a single-center (multi-clinic), open-label, non-randomized pilot study to test whether oral furosemide is safe and effective at increasing urine volume in HD patients. The study will consist of 2 periods: a 6-week dose escalation period (period 1) and a subsequent 12-week follow-up period (period 2). During period 1, all participants will receive escalating doses of furosemide as tolerated, and the short-term safety, tolerability, and efficacy of furosemide will be examined. During period 2, all participants will continue the maximally tolerated period 1 furosemide dose, and the acceptability of and adherence to furosemide and the longer-term safety and efficacy of furosemide will be examined.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient self-report of at least 1 cup urine/24-hours * Age ≥18 years * Receipt of thrice weekly in-center HD at a participating clinic (UNC-associated Carolina Dialysis- Carrboro, Siler City, Pittsboro, Sanford, and Lee County) * ≥60 days receiving in-center HD * Willingness to take study medication and undergo study testing * Ability to provide informed consent

Exclusion criteria

* Known allergy to loop diuretic * History of poor adherence to HD or medical regimen per nephrologist * \>1 hospitalization in prior 30-days * Frequent hypotension (systolic BP \<80 mmHg at \>30% of HD treatments in prior 30-days) * Cirrhosis per nephrologist * Hearing disorder per nephrologist * Serum potassium \<3.5 mEq/L, magnesium \<1 mg/dL, or corrected calcium \<8 mg/dL in prior 30-days * Taking a non-loop diuretic (e.g. spironolactone, eplerenone, ethacrynic acid, thiazides) * Taking an aminoglycoside, cisplatin, methotrexate, cyclosporine, adrenocorticotropic hormone (ACTH), lithium, phenytoin, or oral/intravenous steroid * Natural licorice consumption * Prisoners, patients with significant mental illness * Pregnant patients and nursing mothers

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5Baseline and study week 5 (5 weeks after study medication startParticipants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 5 will be determined.
Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12Baseline and study week 12 (12 weeks after study medication start)Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 12 will be determined.
Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18Baseline and study week 18 (18 weeks after study medication start)Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 18 will be determined.
Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1Study week 1 (1 week after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2Study week 2 (2 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3Study week 3 (3 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4Study week 4 (4 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5Study week 5 (5 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6Study week 6 (6 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9Study week 9 (9 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13Study week 13 (13 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17Study week 17 (17 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1Study week 1 (1 week after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2Study week 2 (2 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3Study week 3 (3 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4Study week 4 (4 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5Study week 5 (5 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6Study week 6 (6 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9Study week 9 (9 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13Study week 13 (13 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 17Study week 17 (17 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 1Study week 1 (1 week after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 2Study week 2 (2 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 3Study week 3 (3 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 4Study week 4 (4 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 5Study week 5 (5 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 6Study week 6 (6 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 9Study week 9 (9 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 13Study week 13 (13 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 17Study week 17 (17 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1.Study week 1 (1 week after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2.Study week 2 (2 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3.Study week 3 (3 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4.Study week 4 (4 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5.Study week 5 (5 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6.Study week 6 (6 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9.Study week 9 (9 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13.Study week 13 (13 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17.Study week 17 (17 weeks after study medication start)Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 1Up to study week 1 (1 week after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 1 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 2Up to study week 2 (2 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 2 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 3Up to study week 3 (3 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 3 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 4Up to study week 4 (4 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 4 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 5Up to study week 5 (5 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 5 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 6Up to study week 6 (6 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 6 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 7Up to study week 7 (7 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 7 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 8Up to study week 8 (8 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 8 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 9Up to study week 9 (9 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 9 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 10Up to study week 10 (10 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 10 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 11Up to study week 11 (11 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 11 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 12Up to study week 12 (12 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 12 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 13Up to study week 13 (13 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 13 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 14Up to study week 14 (14 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 14 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 15Up to study week 15 (15 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 15 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 16Up to study week 16 (16 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 16 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 17Up to study week 17 (17 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 17 will be determined.
Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 18Up to study week 18 (18 weeks after study medication start)Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 18 will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 1Baseline and study week 1 (1 week after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 1. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 2Baseline and study week 2 (2 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 2. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 3Baseline and study week 3 (3 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 3. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 4Baseline and study week 4 (4 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 4. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 5Baseline and study week 5 (5 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 5. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 6Baseline and study week 6 (6 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 6. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 8Baseline and study week 8 (8 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 8. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 10Baseline and study week 10 (10 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 10. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 12Baseline and study week 12 (12 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 12. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 14Baseline and study week 14 (14 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 14. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Change in the Inner EAR Instrument Score From Baseline to Week 16Baseline and study week 16 (16 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 16. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.
Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 18Baseline and study week 18 (18 weeks after study medication start)Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 18. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 3Study week 3 (3 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 3. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 1Study week 1 (1 week after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 1. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 2Study week 2 (2 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 2. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 3Study week 3 (3 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 3. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 4Study week 4 (4 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 4. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 5Study week 5 (5 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 5. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 6Study week 6 (6 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 6. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 8Study week 8 (8 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 8. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 10Study week 10 (10 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 10. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 12Study week 12 (12 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 12. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 14Study week 14 (14 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 14. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 16Study week 16 (16 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 16. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Reporting Acceptance of Furosemide at Week 18Study week 18 (18 weeks after study medication start)Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 18. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1Study week 1 (1 week after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 1. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 2Study week 2 (2 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 2. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 4Study week 4 (4 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 4. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 5Study week 5 (5 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 5. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 6Study week 6 (6 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 6. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 8Study week 8 (8 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 8. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 10Study week 10 (10 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 10. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 12Study week 12 (12 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 12. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 14Study week 14 (14 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 14. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 16Study week 16 (16 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 16. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 18Study week 18 (18 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 18. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.
Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 19Study week 19 (19 weeks after study medication start)Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 19. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Countries

United States

Participant flow

Participants by arm

ArmCount
Study Drug Administration: Furosemide
Study participants will receive furosemide oral tablets to be taken twice daily. During study period 1 (first 6 weeks), the drug dose will be escalated every 2 weeks if safe, tolerated, and acceptable to the participant. During study period 2 (subsequent 12 weeks), participants will take the maximum tolerated dose from study period 1, received every 4 weeks if safe, tolerated, and acceptable to the participant. Furosemide (loop diuretic) Tablets: Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not \>320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose.
39
Total39

Baseline characteristics

CharacteristicStudy Drug Administration: Furosemide
Age, Continuous65 years
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
23 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
14 Participants
Region of Enrollment
United States
39 Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
29 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
2 / 39
other
Total, other adverse events
6 / 39
serious
Total, serious adverse events
8 / 39

Outcome results

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 1

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 1. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 1 (1 week after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 12

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 12. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 12 (12 weeks after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 16

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 16. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 16 (16 weeks after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 3

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 3. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 3 (3 weeks after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 5

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 5. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 5 (5 weeks after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Change in the Inner EAR Instrument Score From Baseline to Week 8

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 8. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score.

Time frame: Baseline and study week 8 (8 weeks after study medication start)

Population: This outcome was entered in error. Data was not collected on this outcome, per the study protocol.

Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 1

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 1. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 38 participants completed the week 1 acceptance assessment. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 197 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 10

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 10. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 28 participants completed the week 10 acceptance assessment. Thus, the analysis population is 28 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 1089 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 12

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 12. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 26 participants completed the week 12 acceptance assessment. Thus, the analysis population is 26 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 1296 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 14

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 14. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 26 participants completed the week 14 acceptance assessment. Thus, the analysis population is 26 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 1496 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 16

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 16. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 26 participants completed the week 16 acceptance assessment. Thus, the analysis population is 26 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 1696 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 18

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 18. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 25 participants completed the week 18 acceptance assessment. Thus, the analysis population is 25 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 1892 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 2

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 2. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 35 participants completed the week 2 acceptance assessment. Thus, the analysis population is 35 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 297 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 3

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 3. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 35 participants completed the week 3 acceptance assessment. Thus, the analysis population is 35 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 394 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 4

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 4. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: Out of the 38 participants still enrolled in the study at week 4, 32 participants completed the week 4 adherence assessment. Thus, the analysis population is 32 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 494 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 5

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 5. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 31 participants completed the week 5 acceptance assessment. Thus, the analysis population is 31 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 590 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 6

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 6. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 31 participants completed the week 6 acceptance assessment. Thus, the analysis population is 31 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 697 Percentage of participants
Primary

Percentage of Participants Reporting Acceptance of Furosemide at Week 8

Participants' acceptance of furosemide will be assessed using an investigator-developed 1-question questionnaire administered at study week 8. Patient-reported acceptance of furosemide at the dose during which the questionnaire is administered will be defined as an affirmative response (yes) to the question If recommended, would you be willing to stay on the dose of furosemide you have received during the last week?. The percentage of participants reporting acceptance of furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 31 participants completed the week 8 acceptance assessment. Thus, the analysis population is 31 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Acceptance of Furosemide at Week 890 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 120 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 140 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious hearing change will be defined as hearing change ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe hearing change attributable to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Hearing Change Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 120 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 140 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious rash will be defined as rash ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting a severe or very severe rash attributable to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting a Severe or Very Severe Rash Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 120 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 140 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious chest pain will be defined as chest pain ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe chest pain will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Chest Pain Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 110 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1017 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 1212 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 149 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 166 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 189 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 216 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 311 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 411 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 517 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 66 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious cramping will be defined as cramping ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe cramping attributable to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Cramping Attributable to Furosemide at Week 88 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 13 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 126 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 146 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious diarrhea will be defined as diarrhea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe diarrhea will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Diarrhea Attributable to Furosemide at Week 83 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 13 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 123 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 140 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 25 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 43 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 56 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious dizziness/pre-syncope will be defined as dizziness/pre-syncope ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe dizziness/pre-syncope attributable to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Dizziness/Pre-syncope Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 15 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 126 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 143 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 33 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 43 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 58 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious nausea will be defined as nausea ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe nausea will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Nausea Attributable to Furosemide at Week 86 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 123 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 143 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 163 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 183 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 33 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 43 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 53 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 63 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious tinnitus will be defined as tinnitus ranked as severe or very severe and attributable to furosemide. Incidence will be defined as percentage of participants who have serious tinnitus. The percentage of participants reporting severe or very severe tinnitus attributable to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Tinnitus Attributable to Furosemide at Week 83 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 123 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 146 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 160 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 180 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the prior week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious unusual tiredness/weakness will be defined as unusual tiredness/weakness ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe unusual tiredness/weakness will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Unusual Tiredness/Weakness Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 1

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 1. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 13 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 10

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 10. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 36 participants completed the week 10 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 100 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 12

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 12. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 34 participants completed the week 12 symptom questionnaire. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 123 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 14

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 14. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 33 participants completed the week 14 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 146 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 16

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 16. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 33 participants completed the week 16 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 163 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 18

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 18. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 33 participants completed the week 18 symptom questionnaire. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 183 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 2

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 2. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 20 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 3

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 3. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 symptom questionnaire. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 30 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 4

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 4. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 38 participants completed the week 4 symptom questionnaire. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 40 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 5

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 5. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 50 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 6

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 6. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 60 Percentage of participants
Primary

Percentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 8

Participants' dialysis-related symptoms during the last week will be assessed using an investigator-developed 13-question symptom questionnaire administered at study week 8. Each symptom will be graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Serious vomiting will be defined as vomiting ranked as severe or very severe and attributable to furosemide. The percentage of participants reporting severe or very severe vomiting will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 36 participants completed the week 8 symptom questionnaire. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Reporting Severe or Very Severe Vomiting Attributable to Furosemide at Week 80 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 1

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 1 will be determined.

Time frame: Up to study week 1 (1 week after study medication start)

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 10 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 10

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 10 will be determined.

Time frame: Up to study week 10 (10 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 10. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 100 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 11

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 11 will be determined.

Time frame: Up to study week 11 (11 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 11. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 110 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 12

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 12 will be determined.

Time frame: Up to study week 12 (12 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 12. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 120 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 13

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 13 will be determined.

Time frame: Up to study week 13 (13 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 13. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 130 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 14

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 14 will be determined.

Time frame: Up to study week 14 (14 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 14. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 140 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 15

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 15 will be determined.

Time frame: Up to study week 15 (15 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 15. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 150 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 16

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 16 will be determined.

Time frame: Up to study week 16 (16 weeks after study medication start)

Population: 34 participants were still enrolled in the study at week 16. Thus, the analysis population is 34 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 160 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 17

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 17 will be determined.

Time frame: Up to study week 17 (17 weeks after study medication start)

Population: 33 participants were still enrolled in the study at week 17. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 170 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 18

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 18 will be determined.

Time frame: Up to study week 18 (18 weeks after study medication start)

Population: 33 participants were still enrolled in the study at week 18. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 180 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 2

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 2 will be determined.

Time frame: Up to study week 2 (2 weeks after study medication start)

Population: 38 participants were still enrolled in the study at week 2. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 20 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 3

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 3 will be determined.

Time frame: Up to study week 3 (3 weeks after study medication start)

Population: 38 participants were still enrolled in the study at week 3. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 30 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 4

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 4 will be determined.

Time frame: Up to study week 4 (4 weeks after study medication start)

Population: 38 participants were still enrolled in the study at week 4. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 40 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 5

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 5 will be determined.

Time frame: Up to study week 5 (5 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 5. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 50 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 6

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 6 will be determined.

Time frame: Up to study week 6 (6 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 6. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 60 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 7

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 7 will be determined.

Time frame: Up to study week 7 (7 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 7. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 70 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 8

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 8 will be determined.

Time frame: Up to study week 8 (8 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 8. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 80 Percentage of participants
Primary

Percentage of Participants That Experience Dialysis-associated Hypotension up to Week 9

Participants' blood pressure will be measured with an upper extremity cuff in a seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Dialysis-associated hypotension will be defined as hypotension during dialysis requiring hospitalization or treatment in an emergency room and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). The percentage of participants who have dialysis-associated hypotension up to week 9 will be determined.

Time frame: Up to study week 9 (9 weeks after study medication start)

Population: 36 participants were still enrolled in the study at week 9. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants That Experience Dialysis-associated Hypotension up to Week 90 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 1. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 36 participants completed the week 1 pill counts. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 167 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 10

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 10. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 10 (10 weeks after study medication start)

Population: 24 participants completed the week 10 pill counts. Thus, the analysis population is 24 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1075 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 12

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 12. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 12 (12 weeks after study medication start)

Population: 24 participants completed the week 12 pill counts. Thus, the analysis population is 24 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1283 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 14

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 14. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 14 (14 weeks after study medication start)

Population: 25 participants completed the week 14 pill counts. Thus, the analysis population is 25 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1484 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 16

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 16. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 16 (16 weeks after study medication start)

Population: 25 participants completed the week 16 pill counts. Thus, the analysis population is 25 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1648 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 18

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 18. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 18 (18 weeks after study medication start)

Population: 24 participants completed the week 18 pill counts. Thus, the analysis population is 24 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1875 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 19

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 19. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 19 (19 weeks after study medication start)

Population: 23 participants completed the week 19 pill counts. Thus, the analysis population is 23 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 1970 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 2

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 2. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: Out of the 38 participants still enrolled in the study at week 2, 32 participants completed the week 2 pill counts. Thus, the analysis population is 32 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 281 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 3

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 3. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 21 participants completed the week 3 pill counts. Thus, the analysis population is 21 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 352 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 4

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 4. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 30 participants completed the week 4 pill counts. Thus, the analysis population is 30 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 467 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 5

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 5. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 27 participants completed the week 5 pill counts. Thus, the analysis population is 27 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 581 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 6

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 6. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 26 participants completed the week 6 pill counts. Thus, the analysis population is 26 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 681 Percentage of participants
Primary

Percentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 8

Participants' adherence to furosemide will be assessed at scheduled pill counts conducted by the study team at study week 8. Participants' adherence to furosemide will be defined \<20% pills remaining at the scheduled pill counts. The percentage of participants who are adherent to furosemide will be determined.

Time frame: Study week 8 (8 weeks after study medication start)

Population: 24 participants completed the week 8 pill counts. Thus, the analysis population is 24 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Are Adherent to Furosemide (<20% Pills Remaining at Scheduled Pill Counts) at Week 867 Percentage of participants
Primary

Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12

Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 12 will be determined.

Time frame: Baseline and study week 12 (12 weeks after study medication start)

Population: Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 33 participants completed the week 12 24-hour urine volume collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 1233 Percentage of participants
Primary

Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18

Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 18 will be determined.

Time frame: Baseline and study week 18 (18 weeks after study medication start)

Population: Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. Out of the 33 participants still enrolled in the study at week 18, 32 completed the week 18 24-hour urine volume collection. Thus, the analysis population is 32 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 1822 Percentage of participants
Primary

Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5

Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 5 will be determined.

Time frame: Baseline and study week 5 (5 weeks after study medication start

Population: Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 36 participants completed the week 5 24-hour urine volume collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 533 percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 10

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 10. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 10 (10 weeks after study medication start)

Population: 36 participants completed the Inner EAR questionnaire at week 10. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 100 Percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 14

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 14. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 14 (14 weeks after study medication start)

Population: 33 participants completed the Inner EAR questionnaire at week 14. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 143 Percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 18

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 18. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 18 (18 weeks after study medication start)

Population: 33 participants completed the Inner EAR questionnaire at week 18. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 186 Percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 2

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 2. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 2 (2 weeks after study medication start)

Population: 37 participants completed the Inner EAR questionnaire at week 2. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 20 Percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 4

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 4. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 4 (4 weeks after study medication start)

Population: 38 participants completed the Inner EAR questionnaire at week 4. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 43 Percentage of participants
Primary

Percentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 6

Participants' hearing ability during the last week will be assessed using the Inner Effectiveness of Auditory Rehabilitation (Inner EAR) 11-question validated questionnaire administered during study week 6. The total instrument score will be tallied at each administration \[range: 10 (low hearing ability) - 59 (high hearing ability)\]. Serious hearing change will be defined as a ≥10-point decrease in the Inner EAR instrument score from baseline score. The percentage of participants with a defined decrease in the Inner EAR instrument score will be determined.

Time frame: Baseline and study week 6 (6 weeks after study medication start)

Population: 36 participants completed the Inner EAR questionnaire at week 6. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Defined Decrease in the Inner EAR Instrument Score From Baseline to Week 60 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 1

Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 10 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 13

Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 13 (13 weeks after study medication start)

Population: 33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 130 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 17

Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 17 (17 weeks after study medication start)

Population: 33 participants completed the week 17 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 170 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 2

Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 20 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 3

Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 30 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 4

Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 37 participants completed the week 4 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 40 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 5

Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 50 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 6

Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 60 Percentage of participants
Primary

Percentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 9

Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum corrected calcium \<7.0 mg/dL will be determined.

Time frame: Study week 9 (9 weeks after study medication start)

Population: 36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Corrected Calcium <7.0 mg/dL at Week 90 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1.

Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 1.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13.

Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 13 (13 weeks after study medication start)

Population: 33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 13.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17.

Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 17 (17 weeks after study medication start)

Population: 33 participants completed the week 17 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 17.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2.

Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 2.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3.

Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 3.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4.

Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 37 participants completed the week 4 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 4.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5.

Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 5.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6.

Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 6.0 Percentage of participants
Primary

Percentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9.

Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum furosemide level \>12 micrograms/L will be determined.

Time frame: Study week 9 (9 weeks after study medication start)

Population: 36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Furosemide Level >12 Micrograms/L at Week 9.0 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1

Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 10 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13

Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 13 (13 weeks after study medication start)

Population: 33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 130 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 17

Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 17 (17 weeks after study medication start)

Population: 33 participants completed the week 17 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 170 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2

Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 20 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3

Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 blood collection. However, there was laboratory error and serum magnesium levels were only available for 36 participants. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 30 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4

Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 37 participants completed the week 4 blood collection. However, there was laboratory error and serum magnesium levels were only available for 36 participants. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 40 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5

Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 50 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6

Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 60 Percentage of participants
Primary

Percentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9

Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum magnesium \<0.8 mEq/L will be determined.

Time frame: Study week 9 (9 weeks after study medication start)

Population: 36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 90 Percentage of participants
Primary

Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1

Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 1 (1 week after study medication start)

Population: 38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With A Serum Potassium <3.2 mEq/L at Week 10 percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13

Blood samples will be collected from participants prior to their dialysis treatments at the week 13 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 13 (13 weeks after study medication start)

Population: 33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 130 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17

Blood samples will be collected from participants prior to their dialysis treatments at the week 17 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 17 (17 weeks after study medication start)

Population: 33 participants completed the week 17 blood collection. Thus, the analysis population is 33 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 170 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2

Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 2 (2 weeks after study medication start)

Population: 37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 20 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3

Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 3 (3 weeks after study medication start)

Population: 37 participants completed the week 3 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 30 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4

Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 4 (4 weeks after study medication start)

Population: 37 participants completed the week 4 blood collection. Thus, the analysis population is 37 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 40 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5

Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 5 (5 weeks after study medication start)

Population: 36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 50 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6

Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 6 (6 weeks after study medication start)

Population: 36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 60 Percentage of participants
Primary

Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9

Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined.

Time frame: Study week 9 (9 weeks after study medication start)

Population: 36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.

ArmMeasureValue (NUMBER)
Study Drug Administration: FurosemidePercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 90 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026