Trial Outcomes & Findings for Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease (NCT NCT02160145)
NCT ID: NCT02160145
Last Updated: 2018-08-08
Results Overview
The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1370 participants
Primary outcome timeframe
Pretreatment baseline to post-treatment follow-up (up to 61 weeks).
Results posted on
2018-08-08
Participant Flow
First subject first visit: 21 May 2014; Last subject last visit: 18 April 2017. Subjects were recruited from 213 sites in 21 countries. Of 2292 subjects screened, 1519 entered the 6-week run-in period; 23 were placebo run-in failures and 126 were tolvaptan titration/run-in failures.
Subjects with Stage 2 - 4 chronic kidney disease (CKD) due to Autosomal Dominant Polycystic Kidney Disease (ADPKD) were stratified by baseline estimated glomerular filtration rate (eGFR) (≤ 45 or \> 45 milliliters/minute/ 1.73 square metres \[mL/min/1.73 m\^2\]), by age (≤ 55 or \> 55 years), and total kidney volume (≤ 2000 mL, \> 2000 mL, or unknown).
Participant milestones
| Measure |
All Subjects Prerandomization
Following screening, the single-blind prerandomization period (Day -42 to Day -1) consisted of:
1. Placebo Run-in: All subjects received a daily split-dose of placebo (0/0 milligrams \[mg\]) in a form identical to 15/15 mg tolvaptan split-dose for 1 week.
2. Tolvaptan Titration: Over 2 weeks all subjects received a split-dose of 30/15 mg (2 x 15mg tablets upon waking, then 1 x 15 mg tablet 8-9 hours later) which was titrated up every 3-4 days to 45/15 mg, then 60/30 mg, and up to a maximum dose of 90/30 mg.
3. Tolvaptan Run-in: Eligible subjects who tolerated at least 60/30 mg tolvaptan during titration entered the 3-week run-in period and continued on a stable dose of 60/30 mg or 90/30 mg tolvaptan to confirm eligibility and establish prerandomization baseline.
|
Tolvaptan
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
Double-blind Randomized Treatment Period (Day 0 to Month 12):
Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|---|
|
Prerandomization Single-blind Period
STARTED
|
1519
|
0
|
0
|
|
Prerandomization Single-blind Period
Treated in Placebo Run-in
|
1514
|
0
|
0
|
|
Prerandomization Single-blind Period
Treated in Tolvaptan Titration/Run-in
|
1491
|
0
|
0
|
|
Prerandomization Single-blind Period
Randomized
|
1370
|
0
|
0
|
|
Prerandomization Single-blind Period
COMPLETED
|
1370
|
0
|
0
|
|
Prerandomization Single-blind Period
NOT COMPLETED
|
149
|
0
|
0
|
|
Randomized Double-blind Period
STARTED
|
0
|
683
|
687
|
|
Randomized Double-blind Period
On-treatment Completers
|
0
|
578
|
637
|
|
Randomized Double-blind Period
Off-treatment Completers
|
0
|
76
|
22
|
|
Randomized Double-blind Period
COMPLETED
|
0
|
654
|
659
|
|
Randomized Double-blind Period
NOT COMPLETED
|
0
|
29
|
28
|
Reasons for withdrawal
| Measure |
All Subjects Prerandomization
Following screening, the single-blind prerandomization period (Day -42 to Day -1) consisted of:
1. Placebo Run-in: All subjects received a daily split-dose of placebo (0/0 milligrams \[mg\]) in a form identical to 15/15 mg tolvaptan split-dose for 1 week.
2. Tolvaptan Titration: Over 2 weeks all subjects received a split-dose of 30/15 mg (2 x 15mg tablets upon waking, then 1 x 15 mg tablet 8-9 hours later) which was titrated up every 3-4 days to 45/15 mg, then 60/30 mg, and up to a maximum dose of 90/30 mg.
3. Tolvaptan Run-in: Eligible subjects who tolerated at least 60/30 mg tolvaptan during titration entered the 3-week run-in period and continued on a stable dose of 60/30 mg or 90/30 mg tolvaptan to confirm eligibility and establish prerandomization baseline.
|
Tolvaptan
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
Double-blind Randomized Treatment Period (Day 0 to Month 12):
Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|---|
|
Prerandomization Single-blind Period
Placebo run-in failure
|
23
|
0
|
0
|
|
Prerandomization Single-blind Period
Tolvaptan titration/run-in failure
|
126
|
0
|
0
|
|
Randomized Double-blind Period
Subject decision
|
0
|
21
|
20
|
|
Randomized Double-blind Period
Lost to Follow-up
|
0
|
1
|
3
|
|
Randomized Double-blind Period
Physician Decision
|
0
|
7
|
5
|
Baseline Characteristics
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Baseline characteristics by cohort
| Measure |
Tolvaptan
n=683 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
n=687 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Total Title
n=1370 Participants
|
|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
690 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
347 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
680 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
632 Participants
n=5 Participants
|
647 Participants
n=7 Participants
|
1279 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
626 Participants
n=5 Participants
|
632 Participants
n=7 Participants
|
1258 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pretreatment baseline to post-treatment follow-up (up to 61 weeks).Population: The primary endpoint efficacy population consisted of all subjects who were in the randomized sample, took at least 1 dose of investigational medicinal product (IMP) after randomization, and had a baseline and at least 1 valid post-treatment evaluation in eGFR (i.e at least 1 week off-treatment).
The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
Outcome measures
| Measure |
Tolvaptan
n=668 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
n=663 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|
|
The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.
|
-2.339 mL/min/1.73 m^2/year
Standard Error 0.240
|
-3.610 mL/min/1.73 m^2/year
Standard Error 0.240
|
SECONDARY outcome
Timeframe: Pretreatment baseline to post-treatment follow-up (up to 61 weeks).Population: The key secondary endpoint efficacy population consisted of all randomized subjects who took at least 1 dose of IMP after randomization, and have a baseline (average of up to 3 eGFR values observed during screening and placebo run-in periods) and at least 1 post-randomization evaluation in eGFR during the double-blind treatment period.
To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula. The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented.
Outcome measures
| Measure |
Tolvaptan
n=680 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
n=682 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|
|
Mean Annualized Slope of eGFR Change
|
-3.160 mL/min/1.73m^2/year
Standard Error 0.140
|
-4.170 mL/min/1.73m^2/year
Standard Error 0.142
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.Population: The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.
The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.
Outcome measures
| Measure |
Tolvaptan
n=681 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
n=685 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|
|
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Month 3
|
10.2 milliosmole per kilogram (mOSm/kg)
Standard Deviation 80.3
|
177.7 milliosmole per kilogram (mOSm/kg)
Standard Deviation 124.5
|
|
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Month 6
|
22.9 milliosmole per kilogram (mOSm/kg)
Standard Deviation 84.3
|
179.1 milliosmole per kilogram (mOSm/kg)
Standard Deviation 126.2
|
|
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Month 9
|
30.4 milliosmole per kilogram (mOSm/kg)
Standard Deviation 92.1
|
179.9 milliosmole per kilogram (mOSm/kg)
Standard Deviation 125.1
|
|
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Month12
|
36.9 milliosmole per kilogram (mOSm/kg)
Standard Deviation 96.0
|
180.3 milliosmole per kilogram (mOSm/kg)
Standard Deviation 121.1
|
|
Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up
Follow-up
|
162.4 milliosmole per kilogram (mOSm/kg)
Standard Deviation 114.0
|
179.5 milliosmole per kilogram (mOSm/kg)
Standard Deviation 128.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.Population: The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.
The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.
Outcome measures
| Measure |
Tolvaptan
n=681 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
Placebo
n=685 Participants
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months.
Follow-up Period: A 3-week final follow-up for efficacy analysis.
|
|---|---|---|
|
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Month 3
|
0.0001 unitless
Standard Deviation 0.0022
|
0.0041 unitless
Standard Deviation 0.0033
|
|
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Month 6
|
0.0003 unitless
Standard Deviation 0.0024
|
0.0042 unitless
Standard Deviation 0.0033
|
|
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Month 9
|
0.004 unitless
Standard Deviation 0.0025
|
0.0040 unitless
Standard Deviation 0.0032
|
|
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Month 12
|
0.0006 unitless
Standard Deviation 0.0027
|
0.0040 unitless
Standard Deviation 0.0033
|
|
Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up
Follow-up
|
0.0037 unitless
Standard Deviation 0.0031
|
0.0040 unitless
Standard Deviation 0.0034
|
Adverse Events
Tolvaptan (Single-blind Treatment Period)
Serious events: 43 serious events
Other events: 1051 other events
Deaths: 1 deaths
Tolvaptan (Double-blind Treatment Period)
Serious events: 85 serious events
Other events: 581 other events
Deaths: 0 deaths
Placebo (Double-blind Treatment Period)
Serious events: 60 serious events
Other events: 564 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tolvaptan (Single-blind Treatment Period)
n=1491 participants at risk
The secondary safety population consisted of all subjects who took at least one dose of tolvaptan during the tolvaptan titration/run-in periods.
|
Tolvaptan (Double-blind Treatment Period)
n=681 participants at risk
The tolvaptan primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of tolvaptan after randomization.
|
Placebo (Double-blind Treatment Period)
n=685 participants at risk
The placebo primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of placebo after randomization.
|
|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/681 • Number of events 4 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Angina Pectoris
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Congenital, familial and genetic disorders
Congenital Hepatic Fibrosis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Abdominal Incarcerated Hernia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Fatigue
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Pyrexia
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Thirst
|
0.13%
2/1491 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Cyst rupture
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Haemorrhagic hepatic cyst
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
HIV infection
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/685 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Renal cyst infection
|
0.13%
2/1491 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Sinusitis
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Hepatic cyst infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/685 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.27%
4/1491 • Number of events 4 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
1.2%
8/681 • Number of events 8 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Blood creatinine increased
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Liver function test abnormal
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/681 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Transaminases increased
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/681 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
1.6%
11/681 • Number of events 12 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.59%
4/681 • Number of events 7 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Psychiatric disorders
Insomnia
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.13%
2/1491 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.20%
3/1491 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.13%
2/1491 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.27%
4/1491 • Number of events 4 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.13%
2/1491 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/681 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/685 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/685 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.44%
3/685 • Number of events 3 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.29%
2/681 • Number of events 2 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Vascular disorders
Hypertension
|
0.07%
1/1491 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/685 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.15%
1/681 • Number of events 1 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
Other adverse events
| Measure |
Tolvaptan (Single-blind Treatment Period)
n=1491 participants at risk
The secondary safety population consisted of all subjects who took at least one dose of tolvaptan during the tolvaptan titration/run-in periods.
|
Tolvaptan (Double-blind Treatment Period)
n=681 participants at risk
The tolvaptan primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of tolvaptan after randomization.
|
Placebo (Double-blind Treatment Period)
n=685 participants at risk
The placebo primary safety population consisted of all subjects who were randomized in the double-blind treatment period and who took at least one dose of placebo after randomization.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
132/1491 • Number of events 134 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.9%
47/681 • Number of events 54 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
3.4%
23/685 • Number of events 25 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Thirst
|
28.8%
430/1491 • Number of events 453 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Fatigue
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.8%
46/681 • Number of events 49 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
3.5%
24/685 • Number of events 27 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
4.4%
30/681 • Number of events 37 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.6%
45/685 • Number of events 50 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
8.7%
59/681 • Number of events 70 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
8.5%
58/685 • Number of events 71 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
5.7%
39/681 • Number of events 48 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
8.0%
55/685 • Number of events 65 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
10.6%
72/681 • Number of events 98 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
12.3%
84/685 • Number of events 111 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.8%
46/681 • Number of events 58 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.7%
46/685 • Number of events 56 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
9.8%
146/1491 • Number of events 147 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
5.0%
34/681 • Number of events 37 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
6.0%
41/685 • Number of events 46 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
8.1%
55/681 • Number of events 66 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
8.6%
59/685 • Number of events 65 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Nocturia
|
20.7%
308/1491 • Number of events 319 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/681 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
0.00%
0/685 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Polyuria
|
31.9%
475/1491 • Number of events 488 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
5.3%
36/681 • Number of events 38 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
1.6%
11/685 • Number of events 11 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
5.4%
37/681 • Number of events 52 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
5.1%
35/685 • Number of events 42 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
16.6%
113/681 • Number of events 158 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
19.0%
130/685 • Number of events 174 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1491 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
10.7%
73/681 • Number of events 88 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
11.5%
79/685 • Number of events 96 • For the tolvaptan single-blind period: 35 days (Day -35 to Day -1). For the double-blind treatment period: 12 months (Day 0 to 12 months).
Treatment emergent adverse events (AEs) were collected, defined as an AE that started after IMP treatment or an AE that was continuous from baseline and was serious, IMP related or resulted in death, discontinuation, interruption or reduction of IMP treatment.
|
Additional Information
Global Clinical Devlopment
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 609 524 6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place