Trial Outcomes & Findings for Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD (NCT NCT02847624)
NCT ID: NCT02847624
Last Updated: 2025-12-10
Results Overview
Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope.
Recruitment status
COMPLETED
Target enrollment
1802 participants
Primary outcome timeframe
Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later).
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
ADPKD
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Overall Study
STARTED
|
1802
|
|
Overall Study
COMPLETED
|
1672
|
|
Overall Study
NOT COMPLETED
|
130
|
Reasons for withdrawal
| Measure |
ADPKD
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Protocol Violation
|
98
|
|
Overall Study
Case report failures
|
4
|
Baseline Characteristics
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
Baseline characteristics by cohort
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1479 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
192 Participants
n=4 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
805 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
867 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1672 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
1672 participants
n=4 Participants
|
|
Weight
|
64.2 kg
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Complication
Hypertension
|
1447 Participants
n=4 Participants
|
|
Complication
Diabetes
|
74 Participants
n=4 Participants
|
|
Complication
Hyperlipidaemia
|
460 Participants
n=4 Participants
|
|
Complication
Hyperuricaemia
|
746 Participants
n=4 Participants
|
|
Complication
Liver disease(Cystic liver)
|
739 Participants
n=4 Participants
|
|
Complication
Liver disease(others)
|
54 Participants
n=4 Participants
|
|
Complication
Pancreatic cysts
|
19 Participants
n=4 Participants
|
|
Complication
Cerebral aneurysm
|
161 Participants
n=4 Participants
|
|
Complication
Kidney disease
|
254 Participants
n=4 Participants
|
|
Complication
Urinary calculus
|
36 Participants
n=4 Participants
|
|
Complication
Cyst infection
|
26 Participants
n=4 Participants
|
|
Complication
Urinary tract infection
|
7 Participants
n=4 Participants
|
|
Predisposition to hypersensitivity
None
|
1411 Participants
n=4 Participants
|
|
Predisposition to hypersensitivity
Medicine
|
49 Participants
n=4 Participants
|
|
Predisposition to hypersensitivity
Foods
|
39 Participants
n=4 Participants
|
|
Predisposition to hypersensitivity
Others
|
144 Participants
n=4 Participants
|
|
Predisposition to hypersensitivity
Missing
|
56 Participants
n=4 Participants
|
|
History of drug adverse reactions
None
|
1536 Participants
n=4 Participants
|
|
History of drug adverse reactions
Any
|
91 Participants
n=4 Participants
|
|
History of drug adverse reactions
Missing
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-administration: From the first pre-treatment measurement (up to 12.5 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later).Population: Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline TKV data. During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment TKV data. Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1,672 cases analyzed for efficacy.
Total Kidney Volume (TKV) was used as a biomarker to assess the progression of ADPKD. TKV was measured at each participating site based on imaging obtained via ultrasound, CT, or MRI. The Estimated Slope pre-administration was calculated for subjects who had TKV measurements both prior to and on the day of Tolvaptan initiation (baseline). The rate of change in TKV from the pre-treatment measurement date to the baseline was used to determine the Estimated Slope. Since the date of initiating tolvaptan administration is considered the start date of the study, the kidney volume measured prior to administration falls outside the study period (i.e., it is a value from before the study start date). The Estimated Slope during-treatment was calculated for subjects who had bilateral TKV measurements at baseline and during the treatment period. The rate of change in TKV from baseline to the measurement date during treatment was used to determine the Estimated Slope.
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Estimated Slope of Total Kidney Volume During Pre-administration and Administration
Pre-administration
|
6.7517 %/year
Standard Deviation 0.2183
|
|
Estimated Slope of Total Kidney Volume During Pre-administration and Administration
During administration
|
3.6811 %/year
Standard Deviation 0.9514
|
SECONDARY outcome
Timeframe: From the date of Tolvaptan initiation to the earlier of either the date when ALT reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).Population: Safety analysis population (n = 1,672)
Among cases included in the safety analysis, we counted and listed the number of patients whose ALT levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672)
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
Baseline
|
1672 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
500 days
|
1210 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
1000 days
|
1007 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
1500 days
|
706 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
2000 days
|
402 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
2500 days
|
47 participants
|
|
The Number of Cases in Which ALT Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
3000 days
|
0 participants
|
SECONDARY outcome
Timeframe: From the date of Tolvaptan initiation to the earlier of either the date when AST reached three times the upper limit of normal or the date of Tolvaptan discontinuation (up to 2789 days).Population: Safety analysis population (n = 1,672)
Among cases included in the safety analysis, we counted and listed the number of patients whose AST levels increased after starting tolvaptan but never exceeded three times the upper limit of normal (30 IU/L) at a specific time point (day) during treatment. Cases in which Tolvaptan treatment was discontinued were considered as dropouts on the day of discontinuation. The number of participants analyzed in each row of the data table is the same as the Overall Number of Participants Analyzed (n=1,672)
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
3000 days
|
0 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
Baseline
|
1672 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
500 days
|
1232 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
1000 days
|
1027 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
1500 days
|
715 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
2000 days
|
413 participants
|
|
The Number of Cases in Which AST Never Exceeded Three Times the Upper Limit of Normal (30 IU/L)
2500 days
|
47 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-administration: From the first pre-treatment measurement (up to 10 years prior) to the start of tolvaptan. During-treatment: From the start of tolvaptan to the final follow-up (up to 8.0 years later).Population: Pre-administration: Estimated slope was calculated in cases with both pre-treatment and baseline e-GFR data. During-treatment: Estimated slope was calculated in cases with both baseline and on-treatment e-GFR data. Because this study used real-world clinical data, not all patients had both sets of measurements required for either group. As a result, the number of cases included in the pre-administration and during-treatment groups was smaller than the total of 1672 cases analyzed for efficacy.
e-GFR was used as a biomarker to evaluate ADPKD progression. Values recorded in the CRF were prioritized; if unavailable, e-GFR was calculated using serum creatinine levels with a gender-specific formula. Male: e-GFR=194×(serum creatinine (mg/dL))\^-1.094 ×(age)\^-0.287 Female: e-GFR=\[194×(serum creatinine (mg/dL))\^-1.094 ×(age)\^-0.287\]×0.739 The pre-treatment Estimated Slope was determined for subjects with e-GFR data both before and at the start of tolvaptan administration (baseline). Since the date of initiating tolvaptan administration is considered the start date of the study, the e-GFR measured prior to administration falls outside the study period. The during-treatment Estimated Slope was calculated for subjects with e-GFR measurements at baseline and during treatment, based on the rate of change from baseline to follow-up.
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration
Pre-administration
|
-3.6272 %/year
Standard Error 0.3572
|
|
Estimated Slope of Estimated Glomerular Filtration Rate (e-GFR) During Pre-administration and Administration
During-treatment
|
-3.2561 %/year
Standard Error 0.0552
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).Population: Elderly patients: Aged 65 years and older Non-elderly patients: Aged under 65 years
The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 192 elderly patients aged 65 years and older, and compared with those in non-elderly patients under 65 years of age.
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older
Elderly patients
|
87 Participants
|
|
The Number and Percentage of Adverse Events Observed in Patients Aged 65 Years and Older
Non-elderly patients
|
690 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).Population: The study cases were divided into the following three groups based on creatinine clearance before administration, and the incidence rate of ADRs was calculated for each group: less than 60 mL/min, 60 to less than 80 mL/min, and 80 mL/min or more.
Adverse events were summarized in patients with advanced ADPKD who had their creatinine clearance measured at the start of tolvaptan treatment. Patients with advanced ADPKD were defined as those with a pre-treatment creatinine clearance of less than 60 mL/min. The incidence rates of Adverse Drug Reactions(ADRs) were calculated for 752 patients with creatinine clearance \<60 mL/min, 261 patients with clearance between 60 and \<80 mL/min, and 331 patients with clearance ≥80 mL/min, and the rates were compared across the creatinine clearance groups.
Outcome measures
| Measure |
ADPKD
n=1344 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Safety in Patients With Advanced ADPKD
creatinine clearance <60 mL/min
|
346 Participants
|
|
Safety in Patients With Advanced ADPKD
creatinine clearance between 60 and <80 mL/min
|
129 Participants
|
|
Safety in Patients With Advanced ADPKD
creatinine clearance ≥80 mL/min
|
157 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).Population: The incidence rate of ADRs was calculated for each time interval from the start of administration. Cases exceeding 36 months were classified as long-term treatment. In cases where the same ADR occurred multiple times in the same patient, all occurrences were included in the calculation.
In the clinical trials conducted prior to approval, there were no cases in which Samsca was administered continuously for more than three years. In this post-marketing surveillance, cases exceeding the three-year (36-month) treatment period of the pre-approval clinical trials were classified as long-term treatment cases. The safety of long-term treatment was evaluated based on the incidence rate of adverse drug reactions (ADRs) according to the timing of their onset.
Outcome measures
| Measure |
ADPKD
n=1672 Participants
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKV slope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Safety of Long-term Treatment for ADPKD
≤7 days
|
201 Participants
|
|
Safety of Long-term Treatment for ADPKD
8-14 days
|
45 Participants
|
|
Safety of Long-term Treatment for ADPKD
15-21 days
|
45 Participants
|
|
Safety of Long-term Treatment for ADPKD
>21 days to ≤3 months
|
165 Participants
|
|
Safety of Long-term Treatment for ADPKD
>3 to ≤6 months
|
174 Participants
|
|
Safety of Long-term Treatment for ADPKD
>6 to ≤9 months
|
129 Participants
|
|
Safety of Long-term Treatment for ADPKD
>9 to ≤12 months
|
78 Participants
|
|
Safety of Long-term Treatment for ADPKD
>12 to ≤24 months
|
129 Participants
|
|
Safety of Long-term Treatment for ADPKD
>24 to ≤36 months
|
120 Participants
|
|
Safety of Long-term Treatment for ADPKD
>36 to ≤48 months
|
56 Participants
|
|
Safety of Long-term Treatment for ADPKD
>48 to ≤60 months
|
40 Participants
|
|
Safety of Long-term Treatment for ADPKD
>60 to ≤72 months
|
30 Participants
|
|
Safety of Long-term Treatment for ADPKD
>72 to ≤84 months
|
3 Participants
|
|
Safety of Long-term Treatment for ADPKD
>84 months
|
1 Participants
|
Adverse Events
ADPKD
Serious events: 253 serious events
Other events: 1086 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
ADPKD
n=1672 participants at risk
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Cardiac disorders
Chronic Heart Failure
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Ascites
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Colonic polyps
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Diarrhea
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Enteritis
|
0.24%
4/1672 • Number of events 4 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
General disorders
Death
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
General disorders
Fever
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
General disorders
Hemorrhagic cyst
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
General disorders
Peripheral edema
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Drug-induced Liver Injury
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Liver Cysts
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Liver Damage
|
0.48%
8/1672 • Number of events 8 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.84%
14/1672 • Number of events 14 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Appendicitis
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Cellulitis
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Diverticulitis
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Infectious Cyst
|
0.78%
13/1672 • Number of events 13 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Liver Cyst Infection
|
0.48%
8/1672 • Number of events 8 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Peritonitis
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Pneumonia
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Pyelonephritis
|
0.24%
4/1672 • Number of events 4 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Renal Cyst Infection
|
1.9%
32/1672 • Number of events 32 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Sepsis
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Septic Shock
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Urinary Tract Infection
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Injury, poisoning and procedural complications
Scar hernia
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.24%
4/1672 • Number of events 4 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increase in Blood Creatinine
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increase in Blood Osmotic Pressure
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increase in C-Reactive Protein
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increase in Liver Enzymes
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Metastasis
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm of the Lung
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.24%
4/1672 • Number of events 4 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Altered state of consciousness
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Cerebral infarction
|
0.18%
3/1672 • Number of events 3 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.30%
5/1672 • Number of events 5 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Putaminal hemorrhage
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.66%
11/1672 • Number of events 11 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.36%
6/1672 • Number of events 6 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
End-Stage Renal Disease
|
0.24%
4/1672 • Number of events 4 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Hematuria
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Renal Cyst Hemorrhage
|
0.90%
15/1672 • Number of events 15 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Renal Dysfunction
|
0.66%
11/1672 • Number of events 11 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Renal Failure
|
0.90%
15/1672 • Number of events 15 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Ureteral Calculi
|
0.30%
5/1672 • Number of events 5 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Reproductive system and breast disorders
Severe menstrual bleeding
|
0.12%
2/1672 • Number of events 2 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Vascular disorders
Aortic Dissection
|
0.30%
5/1672 • Number of events 5 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
Other adverse events
| Measure |
ADPKD
n=1672 participants at risk
Patients with a diagnosis of ADPKD, a TKV of more than 750 mL, and an annual TKVslope increase of more than 5% as measured by magnetic resonance imaging (MRI), computed tomographic (CT) scanning, or ultrasound were included.
|
|---|---|
|
Infections and infestations
Pharyngitis
|
2.8%
46/1672 • Number of events 46 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Infections and infestations
Renal Cyst Infection
|
2.7%
45/1672 • Number of events 45 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
61/1672 • Number of events 61 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
93/1672 • Number of events 93 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.6%
177/1672 • Number of events 177 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Vascular disorders
Hypertension
|
3.0%
50/1672 • Number of events 50 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
35/1672 • Number of events 35 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Liver Function Disorder
|
10.6%
178/1672 • Number of events 178 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Hepatobiliary disorders
Liver Disorder
|
3.5%
59/1672 • Number of events 59 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
44/1672 • Number of events 44 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Renal Failure
|
2.0%
34/1672 • Number of events 34 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Renal and urinary disorders
Renal Dysfunction
|
6.3%
106/1672 • Number of events 106 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
General disorders
Thirst
|
8.1%
135/1672 • Number of events 135 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increased Blood Creatine Phosphokinase
|
2.6%
43/1672 • Number of events 43 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
|
|
Investigations
Increased Blood Creatinine
|
2.2%
36/1672 • Number of events 36 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
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Investigations
Increased Gamma-Glutamyltransferase
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2.2%
36/1672 • Number of events 36 • Adverse events were collected during the period from the start date to the end date of tolvaptan administration for each case (max. 8 years).
The adverse events (if any occurred), onset date, seriousness, reason to have judge the event as serious (in case of serious), outcome, date of outcome judgement, causality to tolvaptan, other possible causal factors, and treatment for adverse events during the observation period were recorded. Seriousness was determined by the physicians.
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Additional Information
Investigator in charge
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd
Phone: +81-6-6943-7722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place