Trial Outcomes & Findings for A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia (NCT NCT00435591)

Last Updated: 2014-05-15

Results Overview

Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant \& represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

121 participants

Primary outcome timeframe

48 hours

Results posted on

2014-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Regimen 1 Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Overall Study STARTED	30	31	30	30
Overall Study Safety Analysis Set	28	30	30	29
Overall Study Full Analysis Set	28	29	30	29
Overall Study End of Treatment	25	27	27	23
Overall Study COMPLETED	23	27	25	19
Overall Study NOT COMPLETED	7	4	5	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=30 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 Participants Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 Participants Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag	Total n=117 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 20.28 • n=5 Participants	61.1 years STANDARD_DEVIATION 20.14 • n=7 Participants	64.8 years STANDARD_DEVIATION 14.13 • n=5 Participants	63.3 years STANDARD_DEVIATION 22.31 • n=4 Participants	62.1 years STANDARD_DEVIATION 19.28 • n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	18 Participants n=4 Participants	61 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	11 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	16 Participants n=4 Participants	60 Participants n=21 Participants
Race/Ethnicity, Customized Black/ African -American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	55 Participants n=21 Participants
Race/Ethnicity, Customized American Indian / Alaskan	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ SIADH	15 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	46 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ CHF	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ Malignancy	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ Idiopathic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ COPD	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ Unknown	6 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	32 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Euvolemic/ Other	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	19 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Hypervolemic/ SIADH	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Hypervolemic/ CHF	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Volume Status/ Underlying Cause of Hyponatremia Hypervolemic/ Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug. The number of participants per arm is consistent for all categories of the data table.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=30 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - 2+	2 Participants	0 Participants	—	—
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - No assessment	0 Participants	1 Participants	—	—
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - 0	17 Participants	16 Participants	—	—
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - 1+	5 Participants	7 Participants	—	—
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - 3+	4 Participants	5 Participants	—	—
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 Infusion Site Reaction - 4+	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment

Population: Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles.

Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. Change from Baseline is calculated as Time point minus Baseline.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=29 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 Participants Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 Participants Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 24 (N= 27; 27; 30; 24)	3.3 mmol/L Standard Deviation 3.23	4.5 mmol/L Standard Deviation 3.85	4.4 mmol/L Standard Deviation 4.43	5.0 mmol/L Standard Deviation 3.81
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 30 (N=27; 28; 28; 23)	3.1 mmol/L Standard Deviation 4.13	4.5 mmol/L Standard Deviation 3.51	4.8 mmol/L Standard Deviation 4.14	4.1 mmol/L Standard Deviation 2.81
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 48.5 (N=26; 28; 28; 27)	4.6 mmol/L Standard Deviation 4.01	5.8 mmol/L Standard Deviation 4.63	6.5 mmol/L Standard Deviation 4.19	5.4 mmol/L Standard Deviation 4.37
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Baseline	124.6 mmol/L Standard Deviation 3.75	123.5 mmol/L Standard Deviation 4.08	124.5 mmol/L Standard Deviation 3.67	124.0 mmol/L Standard Deviation 4.63
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 4 (N=28; 26; 30; 28)	1.2 mmol/L Standard Deviation 3.67	1.5 mmol/L Standard Deviation 2.67	0.7 mmol/L Standard Deviation 2.13	1.9 mmol/L Standard Deviation 3.92
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 6 (N=27; 27; 29; 27)	1.1 mmol/L Standard Deviation 1.96	2.5 mmol/L Standard Deviation 2.88	1.5 mmol/L Standard Deviation 2.70	2.7 mmol/L Standard Deviation 3.23
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 10 (N=27; 28; 30; 26)	2.3 mmol/L Standard Deviation 2.92	2.9 mmol/L Standard Deviation 3.09	2.7 mmol/L Standard Deviation 3.88	2.9 mmol/L Standard Deviation 3.40
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 16 (N=24; 24; 27; 23)	2.0 mmol/L Standard Deviation 2.93	4.0 mmol/L Standard Deviation 4.09	4.2 mmol/L Standard Deviation 3.82	4.8 mmol/L Standard Deviation 3.90
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Hour 40 (N=24; 26; 26; 24)	4.3 mmol/L Standard Deviation 3.01	5.1 mmol/L Standard Deviation 4.14	6.9 mmol/L Standard Deviation 4.68	6.1 mmol/L Standard Deviation 4.52
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period Change at Day 7 (N=23; 27; 25; 17)	6.7 mmol/L Standard Deviation 5.87	9.6 mmol/L Standard Deviation 5.17	7.2 mmol/L Standard Deviation 4.22	8.9 mmol/L Standard Deviation 5.11

SECONDARY outcome

Timeframe: 24.5 hours, 48.5 hours and 96.5 hours

Population: Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table.

AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=29 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 Participants Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 Participants Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours AUCna at 24.5 hours	45.600 hr * mEq/L Standard Deviation 55.919	70.569 hr * mEq/L Standard Deviation 73.042	66.096 hr * mEq/L Standard Deviation 73.662	82.470 hr * mEq/L Standard Deviation 82.195
Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours AUCna at 48.5 hours	133.664 hr * mEq/L Standard Deviation 127.156	194.561 hr * mEq/L Standard Deviation 166.015	205.522 hr * mEq/L Standard Deviation 163.261	207.043 hr * mEq/L Standard Deviation 170.153
Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours AUCna at 96.5 hours	375.379 hr * mEq/L Standard Deviation 331.298	503.127 hr * mEq/L Standard Deviation 340.247	558.926 hr * mEq/L Standard Deviation 351.718	528.377 hr * mEq/L Standard Deviation 371.075

SECONDARY outcome

Timeframe: 48.5 hours

Population: Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table.

The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the "placebo loading dose + YM087 premix continuous infusion" arm will be reported. Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=30 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period	24.08 Hours Interval 16.0 to 40.5	—	—	—

SECONDARY outcome

Timeframe: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours

Population: Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table.

Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=29 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 Participants Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 Participants Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 48.5 Hours	13 Participants	15 Participants	23 Participants	19 Participants
Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 24.5 Hours	6 Participants	13 Participants	13 Participants	10 Participants
Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 96.5 Hours	21 Participants	22 Participants	27 Participants	24 Participants

SECONDARY outcome

Timeframe: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours

Population: Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table.

Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.

Outcome measures

Outcome measures
Measure	Dose Regimen 1 n=28 Participants Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=29 Participants Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 Participants Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 Participants Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 24.5 Hours	1 Participants	6 Participants	7 Participants	6 Participants
Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 96.5 Hours	13 Participants	16 Participants	24 Participants	19 Participants
Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours 0 - 48.5 Hours	6 Participants	13 Participants	17 Participants	12 Participants

Adverse Events

Dose Regimen 1

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Regimen 2

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Dose Regimen 3

Serious events: 8 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose Regimen 4

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dose Regimen 1 n=28 participants at risk Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 2 n=30 participants at risk Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule	Dose Regimen 3 n=30 participants at risk Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag	Dose Regimen 4 n=29 participants at risk Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
Blood and lymphatic system disorders Anaemia	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	13.3% 4/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Gastrointestinal disorders Constipation	10.7% 3/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	16.7% 5/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.7% 2/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	20.0% 6/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	13.8% 4/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
General disorders Chest pain	7.1% 2/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.7% 2/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
General disorders Pyrexia	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.9% 2/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.7% 2/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	13.8% 4/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Nervous system disorders Headache	10.7% 3/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Nervous system disorders Somnolence	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.7% 2/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
Vascular disorders Hypotension	0.00% 0/28 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	0.00% 0/30 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.	6.9% 2/29 Numbers of Participants at Risk represent the Safety Analysis Set (SAF). AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.

Additional Information

Senior Medial Director, Medical Affairs

Astellas Pharma Global Development

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
Publication restrictions are in place

Restriction type: OTHER