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Recruitment challenges and results of interim futility analysis, which showed less than likely to achieve primary endpoint goal-length of hospital stay.
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The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction. The study will also test if tolvaptan is better than fluid restriction in treating the symptoms of hyponatremia in hospitalized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan 15-60mg | Experimental | Oral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response. |
|
| Fluid Restriction | Active Comparator | Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolvaptan | Drug | 15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay (LoS) | LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Dandurand, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otsuka Investigational Site | Birmingham | Alabama | 35216 | United States | ||
| Otsuka Investigational Site |
Participants randomized 1:1 to tolvaptan (15 mg/day,titrated to 30 mg/day or 60 mg/day) without fluid restriction or placebo with titrated fluid restriction (500 to 1500 mL/day). Stratified based on severity of baseline symptoms (3-4, or 5-6 on the Clinical Global Impression of Severity and study center. All partipants were blinded to treatment.
A total of 191 participants were recruited at 81 study sites in the United States (US). A total of 124 participants were randomised to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tolvaptan 15-60 mg/Day | Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Fluid Restriction | Other | Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response. Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose" |
|
| Baseline to 48 hours post dose |
| Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. | Baseline to 24 and 72 hours post dose |
| Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms. | Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed. The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse | Baseline to 48 hours post dose |
| Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]). | Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed. A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose. Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours. | 0 to 72 hours |
| Time to First 2-point Improvement in CGI-S Score. | CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours. | Up to 72 hours |
| Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2. | Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7. | 48 hours post dose |
| Percentage of Participants Requiring Rescue Therapy for Hyponatremia | Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia. | 7 days |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| Otsuka Investigational Site | Mobile | Alabama | 36608 | United States |
| Otsuka Investigational Site | Azusa | California | 91702 | United States |
| Otsuka Investigational Site | Banning | California | 92220 | United States |
| Otsuka Investigational Site | Culver City | California | 90232 | United States |
| Otsuka Investigational Site | Fountain Valley | California | 92708 | United States |
| Otsuka Investigational Site | Los Angeles | California | 90025 | United States |
| Otsuka Investigational Site | Los Angeles | California | 90033 | United States |
| Otsuka Investigational Site | Northridge | California | 91324 | United States |
| Otuska Investigational Site | Orange | California | 92868 | United States |
| Otsuka Investigational Site | Yorba Linda | California | 92886 | United States |
| Otsuka Investigational Site | Denver | Colorado | 80210 | United States |
| Otsuka Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Otsuka Investigational Site | Jacksonville | Florida | 32207 | United States |
| Otsuka Investigational Site | Jacksonville | Florida | 32209 | United States |
| Otsuka Investigational Site | Jacksonville | Florida | 32216 | United States |
| Otsuka Investigational Site | Orlando | Florida | 32803 | United States |
| Otsuka Investigational Site | Port Charlotte | Florida | 33952 | United States |
| Otsuka Investigational Site | Savannah | Georgia | 31405 | United States |
| Otsuka Investigational Site | Elizabethtown | Kentucky | 42701 | United States |
| Otsuka Investigational Site | Baltimore | Maryland | 21215 | United States |
| Otsuka Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Otsuka Investigational Site | Saginaw | Michigan | 48602 | United States |
| Otsuka Investigational Site | Southfield | Michigan | 48075 | United States |
| Otsuka Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Otsuka Investigational Site | Rochester | Minnesota | 55905 | United States |
| Otsuka Investigational Site | Jackson | Mississippi | 39216 | United States |
| Otsuka Investigational Site | St Louis | Missouri | 63110 | United States |
| Otsuka Investigational Site | Grand Island | Nebraska | 68803 | United States |
| Otsuka Investigational Site | Omaha | Nebraska | 68131 | United States |
| Otsuka Investigational Site | Haddon Heights | New Jersey | 08035 | United States |
| Otsuka Investigational Site | Newark | New Jersey | 07103 | United States |
| Otsuka Investigational Site | Buffalo | New York | 14203 | United States |
| Otsuka Investigational Site | Buffalo | New York | 14215 | United States |
| Otsuka Investigational Site | Jamaica | New York | 11418 | United States |
| Otsuka Investigational Site | New York | New York | 10032 | United States |
| Otsuka Investigational Site | The Bronx | New York | 10461 | United States |
| Otsuka Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Otsuka Investigational Site | Cleveland | Ohio | 44195 | United States |
| Otsuka Investigational Site | Columbus | Ohio | 43212 | United States |
| Otsuka Investigational Site | Fairfield | Ohio | 45014 | United States |
| Otsuka Investigational Site | Toledo | Ohio | 43560 | United States |
| Otsuka Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| Otsuka Investigational Site | Bethleham | Pennsylvania | 18017 | United States |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| Otsuka Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Otsuka Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| Otsuka Investigational Site | Providence | Rhode Island | 02903 | United States |
| Otsuka Investigational Site | Galveston | Texas | 77555 | United States |
| Otsuka Investigational Site | Houston | Texas | 77030 | United States |
| Otsuka Investigational Site | Mission | Texas | 78572 | United States |
| Otsuka Investigational Site | San Antonio | Texas | 78205 | United States |
| Otsuka Investigational Site | San Antonio | Texas | 78229 | United States |
| Otsuka Investigational Site | Fairfax | Virginia | 22030 | United States |
| Otsuka Investigational Site | Madison | Wisconsin | 53705 | United States |
Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tolvaptan 15-60 mg/Day | Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response. |
| BG001 | Placebo | Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Length of Hospital Stay (LoS) | LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. | Posted | Median | 95% Confidence Interval | Days | 45 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms. | Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for one participant in the Tolvaptan group. | Posted | Median | Full Range | Units on a scale | Baseline to 48 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms. | Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed. The CGI-S is a one-question rating scale which was as follows: "Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?" 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for one participant in the Tolvaptan group. | Posted | Median | Full Range | Units on a scale | Baseline to 24 and 72 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms. | Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed. The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group. | Posted | Median | Full Range | Units on a scale | Baseline to 48 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]). | Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed. A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose. Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group. | Posted | Least Squares Mean | Full Range | mEq/L | 0 to 72 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First 2-point Improvement in CGI-S Score. | CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group. | Posted | Median | 95% Confidence Interval | Hours | Up to 72 hours |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2. | Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group. | Posted | Number | Percentage of participants | 48 hours post dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Rescue Therapy for Hyponatremia | Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia. | Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group. | Posted | Number | Percentage of participants | 7 days |
|
|
Adverse events were recorded from the time the Informed Consent Form was signed up to 45 days after study drug administration.
The same event may appear as both an adverse event (AE) and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tolvaptan 15-60 mg/Day | Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response. | 18 | 66 | 52 | 66 | ||
| EG001 | Placebo | Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response. | 9 | 55 | 43 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Tuberculosis of central nervous system | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Small cell lung cancer extensive stage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Rapid correction of hyponatraemia | Surgical and medical procedures | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | Med DRA 15.1 | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development and Commercialization, Inc. | 800 562-3974 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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