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The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Regimen 1 | Experimental | Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule |
|
| Dose Regimen 2 | Experimental | Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule |
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| Dose Regimen 3 | Experimental | Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag |
|
| Dose Regimen 4 | Experimental | Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conivaptan | Drug | ampoule or premix bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 | Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period | Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. Change from Baseline is calculated as Time point minus Baseline. | Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleston | South Carolina | 29425 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21411800 | Background | Kalra S, Efrati S, Arthur JM, Oliven A, Velez JC, McNutt BE, Klasen S, Abeyratne A. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 Apr 1;68(7):590-8. doi: 10.2146/ajhp100243. |
| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Regimen 1 | Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule |
| FG001 | Dose Regimen 2 | Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | ampoule or premix bag |
|
| Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours | AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | 24.5 hours, 48.5 hours and 96.5 hours |
| Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period | The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the "placebo loading dose + YM087 premix continuous infusion" arm will be reported. Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | 48.5 hours |
| Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours | Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | 0-24.5 hours, 0-48.5 hours and 0-96.5 hours |
| Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours | Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | 0-24.5 hours, 0-48.5 hours and 0-96.5 hours |
| Bangalore |
| 560034 |
| India |
| Bangalore | 560099 | India |
| Bhopal | 462001 | India |
| Hyderabaad | 500482 | India |
| Karnāl | 132001 | India |
| Afula | 18101 | Israel |
| Ashkelon | 78308 | Israel |
| Haifa | 31048 | Israel |
| Haifa | 34362 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 910301 | Israel |
| Jerusalem | 91120 | Israel |
| Rehovot | 76100 | Israel |
| Safed | 13100 | Israel |
| Tel Aviv | 64239 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Ẕerifin | 70300 | Israel |
| FG002 | Dose Regimen 3 | Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag |
| FG003 | Dose Regimen 4 | Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag |
| Safety Analysis Set |
|
| Full Analysis Set |
|
| End of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Regimen 1 | Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule |
| BG001 | Dose Regimen 2 | Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule |
| BG002 | Dose Regimen 3 | Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag |
| BG003 | Dose Regimen 4 | Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag |
| BG004 | 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 | Population represented is Safety Analysis Set (SAF) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Population represented is Safety Analysis Set (SAF) | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Population represented is Safety Analysis Set (SAF) | Number | Participants |
| |||||||||||||||
| Volume Status/ Underlying Cause of Hyponatremia | Population represented is Safety Analysis Set (SAF) SIADH: Syndrome of inappropriate antidiuretic hormone secretion CHF: Congestive heart failure COPD: Chronic obstructive pulmonary disease | Number | 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 | Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2 | Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis | Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug. The number of participants per arm is consistent for all categories of the data table. | Posted | Number | Participants | 48 hours |
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| Secondary | Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period | Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. Change from Baseline is calculated as Time point minus Baseline. | Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles. | Posted | Mean | Standard Deviation | mmol/L | Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment |
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| Secondary | Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours | AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table. | Posted | Mean | Standard Deviation | hr * mEq/L | 24.5 hours, 48.5 hours and 96.5 hours |
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| Secondary | Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period | The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the "placebo loading dose + YM087 premix continuous infusion" arm will be reported. Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table. | Posted | Median | Inter-Quartile Range | Hours | 48.5 hours |
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| Secondary | Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours | Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table. | Posted | Number | Participants | 0-24.5 hours, 0-48.5 hours and 0-96.5 hours |
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| Secondary | Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours | Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L. Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period. | Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data. The number of participants per arm is consistent for all categories of the data table. | Posted | Number | Participants | 0-24.5 hours, 0-48.5 hours and 0-96.5 hours |
|
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Numbers of Participants at Risk represent the Safety Analysis Set (SAF).
AE collection began at the start of study drug infusion and continued through Post Treatment Period Day 7. AEs collected in this time interval were defined as treatment emergent AEs (TEAEs) for patients who completed or prematurely discontinued study drug.
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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 | Dose Regimen 1 | Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule | 2 | 28 | 6 | 28 | ||
| EG001 | Dose Regimen 2 | Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule | 5 | 30 | 12 | 30 | ||
| EG002 | Dose Regimen 3 | Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag | 8 | 30 | 4 | 30 | ||
| EG003 | Dose Regimen 4 | Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag | 2 | 29 | 8 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Collapse of lung | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
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| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Haemodialysis | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
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Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medial Director, Medical Affairs | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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| Male |
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| Black/ African -American |
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| Asian |
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| American Indian / Alaskan |
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| Euvolemic/ CHF |
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| Euvolemic/ Malignancy |
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| Euvolemic/ Idiopathic |
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| Euvolemic/ COPD |
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| Euvolemic/ Unknown |
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| Euvolemic/ Other |
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| Hypervolemic/ SIADH |
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| Hypervolemic/ CHF |
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| Hypervolemic/ Unknown |
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| Infusion Site Reaction - 1+ |
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| Infusion Site Reaction - 2+ |
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| Infusion Site Reaction - 3+ |
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| Infusion Site Reaction - 4+ |
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| OG003 |
| Dose Regimen 4 |
Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag |
|
|
| OG003 |
| Dose Regimen 4 |
Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag |
|
|
|
| Dose Regimen 4 |
Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag |
|
|
| OG003 | Dose Regimen 4 | Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag |
|
|