Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Conditions
Keywords
Hyponatremia due to SIADH, tolvaptan
Brief summary
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Europe Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable. * Female and/or male patients aged 18 years and over. * Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.
Exclusion criteria
* A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge | From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) | The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sodium Levels 24 Hours After Treatment Initiation | From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards | Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan |
| Change in Sodium Levels 6 Weeks After Treatment Initiation | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6 |
| Time (Hours) to Sodium Normalisation | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | Time (hours) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). |
| Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Baseline | Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records |
| Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) | Baseline | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records |
| Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | Baseline | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records |
| Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). |
| Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Baseline | specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records |
| Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). |
| Time (Days) to Sodium Normalisation | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | Time (days) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation | Only medications taken by more than 5% of the study population are presented |
| Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | From 12 months up to baseline (tolvaptan treatment initiation) | Only medications taken by more than 5% of the study population are presented |
Countries
Germany, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tolvaptan Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Tolvaptan |
|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 14.41 |
| Body Mass Index | 25.781 Kg/m^2 STANDARD_DEVIATION 5.289 |
| Height | 1.632 meters STANDARD_DEVIATION 0.0831 |
| Region of Enrollment Germany | 44 participants |
| Region of Enrollment Spain | 56 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 47 Participants |
| Weight | 68.8 kg STANDARD_DEVIATION 15.03 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 100 |
| other Total, other adverse events | 12 / 100 |
| serious Total, serious adverse events | 10 / 100 |
Outcome results
Primary
Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge
The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).
Time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
Population: Baseline sodium level was not available for 4 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolvaptan | Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge | 10.3 mmol/L | Standard Deviation 6.42 |
Secondary
Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study
Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolvaptan | Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study | 12.67 mg | Standard Deviation 9.173 |
Secondary
Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study
Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolvaptan | Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study | 27.96 days | Standard Deviation 16.479 |
Secondary
Change in Sodium Levels 24 Hours After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan
Time frame: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
Population: Only patients with a value at both baseline and 24 hours of initiation of tovaptan were included in the change from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolvaptan | Change in Sodium Levels 24 Hours After Treatment Initiation | 3.3 mmol/L | Standard Deviation 4.53 |
Secondary
Change in Sodium Levels 6 Weeks After Treatment Initiation
Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Population: only patients with a value at both baseline and that time point are included in the change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tolvaptan | Change in Sodium Levels 6 Weeks After Treatment Initiation | 11.8 mmol/L | Standard Deviation 6.45 |
Secondary
Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia
symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | lethargy | 41 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | gait disorder | 37 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | nausea | 33 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | disorientation | 31 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | drowsiness | 30 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | anorexia | 28 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | confusion | 28 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | vomiting | 24 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | restlessness | 15 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | brain damage | 10 Participants |
| Tolvaptan | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | headache | 10 Participants |
Secondary
Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)
Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Hereditary causes | 3 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Other (mainly unknown/idiopathic origin) | 32 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Cancer | 27 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Medication | 20 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | CNS disorder | 11 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Pulmonary disease | 7 % of participants |
Secondary
Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)
specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Endocrinology | 40 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Nephrology | 25 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Internal medicine | 19 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Emergency Room Dept | 6 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Oncology | 5 % of participants |
| Tolvaptan | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | Other | 5 % of participants |
Secondary
Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)
symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tolvaptan | Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) | 83 Participants |
Secondary
Time (Days) to Sodium Normalisation
Time (days) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tolvaptan | Time (Days) to Sodium Normalisation | 7 days |
Secondary
Time (Hours) to Sodium Normalisation
Time (hours) to sodium normalisation, defined as a serum sodium level \> 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Population: Exact time was available for 64 patients, so the analysis in hours had a n=64
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tolvaptan | Time (Hours) to Sodium Normalisation | 115.5 hours |
Other Pre-specified
Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)
Only medications taken by more than 5% of the study population are presented
Time frame: From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Metoprolol succinate | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Metoclopramide | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Bisoprolol | 6 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Acetylsalicylic acid | 27 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Omeprazole | 25 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Amlodipine | 23 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Ramipril | 18 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Dexomethasone | 15 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Pantoprazole | 15 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Enoxaparin | 14 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Lorazepam | 14 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Metamizole | 13 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Simvastatin | 13 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Acetominophen | 11 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Levothyroxine | 10 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Metformin | 10 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Enalapril | 10 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Torasemide | 8 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Ondansetron | 8 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Fursosemide | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Insulin | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Levetiracetam | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Lactulose | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Atorvastatin | 7 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Metoprolol | 6 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Normal saline | 6 Participants |
| Tolvaptan | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Salbutamol | 6 Participants |
Other Pre-specified
Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)
Only medications taken by more than 5% of the study population are presented
Time frame: From 12 months up to baseline (tolvaptan treatment initiation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tolvaptan | Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Furosemide | 10 Participants |
| Tolvaptan | Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Levofloxavin | 7 Participants |
| Tolvaptan | Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Normal Saline | 6 Participants |
Post Hoc
Time (Days) to Hospital Discharge up to 6 Weeks After Treatment Start
Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Population: Originally, the idea was to analyse this out come in hours, but due to missing data, it was also analysed in days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tolvaptan | Time (Days) to Hospital Discharge up to 6 Weeks After Treatment Start | 7.0 days |