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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards |
| Change in Sodium Levels 6 Weeks After Treatment Initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation |
Inclusion Criteria:
Exclusion Criteria:
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Eligible patients are ≥ 18 years old and have been treated with at least 2 doses of tolvaptan for one occurrence of hyponatraemia secondary to SIADH during 2014. If the number of patients treated with tolvaptan in 2014 in the participating centres is not sufficient to reach the intended sample size, this retrospective enrolment period could be extended to include patients treated in 2013.
A mix of centres and treating departments (e.g. endocrinology, nephrology, etc.), will be selected within each participating country in order to provide a sufficiently representative sample of patients treated with tolvaptan for hyponatraemia secondary to SIADH.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Department | Otsuka Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bochum | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33306187 | Derived | Pose-Reino A, Runkle de la Vega I, de Jong-Laird A, Kabra M, Lindner U. Real-World, Non-Interventional, Retrospective Study (SAMPLE) of Tolvaptan in Patients with Hyponatraemia Secondary to the Syndrome of Inappropriate Antidiuretic Hormone Secretion. Adv Ther. 2021 Feb;38(2):1055-1067. doi: 10.1007/s12325-020-01560-2. Epub 2020 Dec 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan | Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6 |
| From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
| 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). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
| 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 | Baseline |
| 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 | Baseline |
| 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 | Baseline |
| 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). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
| 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). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
| 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 | Baseline |
| 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). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
| 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 |
| From 12 months up to baseline (tolvaptan treatment initiation) |
| Chemnitz |
| Germany |
| Dresden | Germany |
| Lübeck | Germany |
| Córdoba | Spain |
| Madrid | Spain |
| Santiago de Compostela | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan | Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | number of patients meeting the criterion | Mean | Standard Deviation | kg |
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| Height | number of patients meeting the criterion | Mean | Standard Deviation | meters |
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| Body Mass Index | number of patients meeting the criterion. | Mean | Standard Deviation | Kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Baseline sodium level was not available for 4 patients | Posted | Mean | Standard Deviation | mmol/L | From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) |
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| 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 | Only patients with a value at both baseline and 24 hours of initiation of tovaptan were included in the change from baseline | Posted | Mean | Standard Deviation | mmol/L | From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards |
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| 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 | only patients with a value at both baseline and that time point are included in the change | Posted | Mean | Standard Deviation | mmol/L | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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). | Exact time was available for 64 patients, so the analysis "in hours" had a n=64 | Posted | Median | 95% Confidence Interval | hours | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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 | Posted | Number | % of participants | Baseline |
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| 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 | Posted | Count of Participants | Participants | Baseline |
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| 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 | Posted | Number | % of participants | Baseline |
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| 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). | Posted | Mean | Standard Deviation | mg | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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). | Posted | Median | 95% Confidence Interval | days | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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 | Posted | Count of Participants | Participants | From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation |
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| Post-Hoc | Time (Days) to Hospital Discharge up to 6 Weeks After Treatment Start | Originally, the idea was to analyse this out come in "hours", but due to missing data, it was also analysed in "days". | Posted | Median | 95% Confidence Interval | days | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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 | Posted | Count of Participants | Participants | Baseline |
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| 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). | Posted | Mean | Standard Deviation | days | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
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| 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 | Posted | Count of Participants | Participants | From 12 months up to baseline (tolvaptan treatment initiation) |
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Study period was defined for each patient as: from start of tolvaptan treatment until 6 weeks afterwards maximum.
Treatment-emergent adverse event defined as adverse event (AEs) that started or worsened after the start of the administration of tolvaptan, i.e. meaning temporal association but not necessarily causality/relationship (investigators were not asked about this).
Please note that collection of AE, as the study itself, was retrospective.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tolvaptan | Adult patients who received at least 2 doses of tolvaptan for the treatment of one occurrence of hyponatraemia secondary to SIADH. | 3 | 100 | 10 | 100 | 12 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WOUND INFECTION | Infections and infestations | MedDra (18.0) | Systematic Assessment | INFECTION OF OPEN FRACTURES |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDra (18.0) | Systematic Assessment | HYPONATREMIA EPISODE |
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| URINARY TRACT INFECTION | Infections and infestations | MedDra (18.0) | Systematic Assessment |
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| DEATH | General disorders | MedDra (18.0) | Systematic Assessment | NATURAL DEATH (EXTREMELY OLD DEATH) |
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| BLOOD SODIUM INCREASED | Investigations | MedDra (18.0) | Systematic Assessment | RAPID RAISE IN SODIUM LEVELS |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDra (18.0) | Systematic Assessment | NEUTROPENIA POST-CHEMOTHERAPY |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment | Fatal for 1 patient. |
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| EPILEPSY | Nervous system disorders | MedDra (18.0) | Systematic Assessment | EPILEPTIC SEIZURE |
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| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (18.0) | Systematic Assessment | EXITUS BY SMALL CELL LUNG CANCER |
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| SYNCOPE | Nervous system disorders | MedDra (18.0) | Systematic Assessment |
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| MENINGITIS | Infections and infestations | MedDra (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THIRST | General disorders | MedDra (18.0) | Systematic Assessment |
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| EAR INFECTION | Infections and infestations | MedDra (18.0) | Systematic Assessment | OTITIS |
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| ORAL CANDIDIASIS | Infections and infestations | MedDra (18.0) | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDra (18.0) | Systematic Assessment |
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| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDra (18.0) | Systematic Assessment | ACUTE COLANGITIS WITH FEVER AND ELEVATION OF LIVER ENZYMES |
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| BLOOD SODIUM DECREASED | Investigations | MedDra (18.0) | Systematic Assessment |
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| BLOOD SODIUM ABNORMAL | Investigations | MedDra (18.0) | Systematic Assessment | NO IMPROVE SODIUM LEVELS |
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| DIARRHOEA | Gastrointestinal disorders | MedDra (18.0) | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDra (18.0) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDra (18.0) | Systematic Assessment |
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| BLOOD SODIUM INCREASED | Investigations | MedDra (18.0) | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDra (18.0) | Systematic Assessment |
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| SEIZURE | Nervous system disorders | MedDra (18.0) | Systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDra (18.0) | Systematic Assessment |
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As a multicentre study, the first publication shall be based on consolidated analysed data from all centres, i.e. the publication of results from individual institution/Investigator is not allowed before the publication of the full study results.
The PI agrees to give the sponsor 60 days to review the communications. If case of propietary information inadvertenly divulged, intellectual property rights at risk or inaccurate information presented, changes can be required by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Department | Otsuka Pharmaceutical Europe Ltd. | +44(0)2037475000 |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| Title | Denominators | Categories | ||||
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| Cancer |
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| Medication |
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| CNS disorder |
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| Pulmonary disease |
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| Hereditary causes |
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| Other (mainly unknown/idiopathic origin) |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
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| lethargy |
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| gait disorder |
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| nausea |
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| disorientation |
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| drowsiness |
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| anorexia |
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| confusion |
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| vomiting |
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| restlessness |
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| brain damage |
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| headache |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Furosemide |
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| Levofloxavin |
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| Normal Saline |
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