Trial Outcomes & Findings for Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (NCT NCT01336972)
NCT ID: NCT01336972
Last Updated: 2019-03-05
Results Overview
Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
After 3 weeks of treatment and 3 weeks post treatment
Results posted on
2019-03-05
Participant Flow
The trial was conducted in 29 participants at one center in The Netherlands. Participants were stratified based on their estimated glomerular filtration rate (eGFR): \>60, 30-60 and \<30 millilitres (mL)/minute (min)/1.73 meter squared (m2). eGFR was assessed using the 4-variable modification of diet in renal disease (MDRD).
The trial consisted of a 2- to 42-day screening period, a 3-week treatment period, and a 3-week post treatment period.
Participant milestones
| Measure |
eGFR > 60 mL/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 ml/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
eGFR > 60 mL/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 ml/Min/1.73m2
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Baseline characteristics by cohort
| Measure |
eGFR > 60 mL/Min/1.73m2
n=10 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=10 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.7 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
47.8 Years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
52.1 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
46.0 Years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After 3 weeks of treatment and 3 weeks post treatmentPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
-8.0 mL/min
Standard Deviation 9.1
|
-6.2 mL/min
Standard Deviation 6.2
|
-0.7 mL/min
Standard Deviation 1.5
|
|
Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
0.1 mL/min
Standard Deviation 4.9
|
-1.5 mL/min
Standard Deviation 4.0
|
-1.2 mL/min
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: After 3 weeks of treatment and 3 weeks post treatmentPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
-16.9 mL/min
Standard Deviation 36.4
|
-11.1 mL/min
Standard Deviation 18.4
|
-1.7 mL/min
Standard Deviation 5.1
|
|
Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
4.3 mL/min
Standard Deviation 30.2
|
-8.4 mL/min
Standard Deviation 17.7
|
-1.3 mL/min
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: After 3 weeks of treatment and 3 weeks post treatmentPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
-0.005 Ratios
Standard Deviation 0.017
|
-0.013 Ratios
Standard Deviation 0.016
|
-0.010 Ratios
Standard Deviation 0.014
|
|
Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
-0.003 Ratios
Standard Deviation 0.018
|
0.005 Ratios
Standard Deviation 0.015
|
-0.016 Ratios
Standard Deviation 0.023
|
SECONDARY outcome
Timeframe: After 3 weeks of treatment and 3 weeks post treatmentPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment
Final treatment change from Baseline
|
4.334 mL/min
Standard Deviation 3.268
|
2.822 mL/min
Standard Deviation 1.715
|
1.701 mL/min
Standard Deviation 1.225
|
|
Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment
Post treatment change from Baseline
|
-0.675 mL/min
Standard Deviation 1.475
|
-0.195 mL/min
Standard Deviation 1.124
|
0.382 mL/min
Standard Deviation 0.543
|
SECONDARY outcome
Timeframe: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hourPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=8 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.
|
828 ng/mL
Standard Deviation 297
|
591 ng/mL
Standard Deviation 235
|
840 ng/mL
Standard Deviation 355
|
SECONDARY outcome
Timeframe: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hourPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=8 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.
|
2.0 hours
Interval 1.0 to 3.0
|
2.0 hours
Interval 1.0 to 3.0
|
2.0 hours
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hourPopulation: All participants who took any trial medication and had a postbaseline renal function test.
Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits. At the Final Treatment visit (Day 21 \[+/- 1 day)\]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose. At the Baseline (Day 0), and Post Treatment visit (3 weeks \[+/-3 days\] after last dose), a blood sample was collected prior to the start of infusion of study treatment.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=8 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.
|
2850 ng.h/mL
Standard Deviation 774
|
2140 ng.h/mL
Standard Deviation 863
|
3100 ng.h/mL
Standard Deviation 1060
|
SECONDARY outcome
Timeframe: After 3 weeks of treatment and 3 weeks post treatmentPopulation: All participants who took any trial medication and had a postbaseline renal function test.
TKV was measured using magnetic resonance imaging.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
-1.5 Percent
Standard Deviation 2.3
|
-2.4 Percent
Standard Deviation 3.8
|
-0.7 Percent
Standard Deviation 2.5
|
|
Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
-4.5 Percent
Standard Deviation 3.7
|
-4.6 Percent
Standard Deviation 2.7
|
-1.9 Percent
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All participants who took any trial medication and had a postbaseline renal function test.
A 24-hour split urine sample (approximate times: 0700 to 1700 hours, 1700 hours to bedtime, and bedtime to 0700 hours) was collected beginning the day before the Baseline, Final Treatment, and Post Treatment visits and ending at admission to the renal function ward. Individual voids in a collection interval were pooled and the total volume determined.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
4551.1 mL
Standard Deviation 1792.7
|
3274.4 mL
Standard Deviation 1293.3
|
2215.0 mL
Standard Deviation 1142.0
|
|
Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
-312.2 mL
Standard Deviation 468.2
|
-287.2 mL
Standard Deviation 744.7
|
143.1 mL
Standard Deviation 390.4
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: All participants who took any trial medication and had a postbaseline renal function test.
The volume of urine from each 2-hour urine collection in the renal function tests at Baseline, Final Treatment, and Post Treatment was recorded. Individual voids in a collection interval were pooled before determination of total volume.
Outcome measures
| Measure |
eGFR > 60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 Participants
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability
|
|---|---|---|---|
|
Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.
Final treatment change from Baseline
|
888.9 mL
Standard Deviation 730.3
|
625.6 mL
Standard Deviation 478.5
|
356.7 mL
Standard Deviation 283.2
|
|
Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.
Post treatment change from Baseline
|
-187.8 mL
Standard Deviation 218.2
|
-10.0 mL
Standard Deviation 335.1
|
27.5 mL
Standard Deviation 155.0
|
Adverse Events
eGFR > 60 mL/Min/1.73m2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
eGFR 30-60 mL/Min/1.73m2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
eGFR <30 mL/Min/1.73m2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
eGFR > 60 mL/Min/1.73m2
n=10 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=10 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
|---|---|---|---|
|
Renal and urinary disorders
Polyuria
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
Other adverse events
| Measure |
eGFR > 60 mL/Min/1.73m2
n=10 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR 30-60 mL/Min/1.73m2
n=10 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
eGFR <30 mL/Min/1.73m2
n=9 participants at risk
Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Eye disorders
Conjunctival haemorrhage
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Dry mouth
|
60.0%
6/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
50.0%
5/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
55.6%
5/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
22.2%
2/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
General disorders
Fatigue
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
33.3%
3/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
General disorders
Malaise
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
General disorders
Oedema
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
22.2%
2/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
General disorders
Thirst
|
100.0%
10/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
100.0%
10/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
88.9%
8/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Investigations
Skin turgor decreased
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
30.0%
3/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
22.2%
2/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
20.0%
2/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
22.2%
2/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
22.2%
2/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Renal and urinary disorders
Nocturia
|
80.0%
8/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
60.0%
6/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
66.7%
6/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Renal and urinary disorders
Polyuria
|
90.0%
9/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
90.0%
9/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
77.8%
7/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Renal and urinary disorders
Renal pain
|
30.0%
3/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Social circumstances
Family stress
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Social circumstances
Stress at work
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Vascular disorders
Fushing
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
11.1%
1/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/10 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
0.00%
0/9 • Adverse events were collected from the time of signing the informed consent to 7 days after the early termination visit or up to the 21 Day Post-Treatment Visit
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place