Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AA021840-01 | U.S. NIH Grant/Contract | View source | |
| U01AA021883 | U.S. NIH Grant/Contract | View source | |
| U01AA021891 | U.S. NIH Grant/Contract | View source | |
| U01AA021788 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Post-marketing reports of hepatotoxicity associated with obeticholic acid emerged in June 2017, investigators temporarily halted patient recruitment June 2017.
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Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Intercept Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
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The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 10 mg Obeticholic Acid (OCA) | Experimental | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MELD Score Mean(SD) | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | Baseline to 6 weeks (Day 42) |
| Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Baseline to 6 weeks (Day 42) |
| MELD Score Change From Baseline Mean(SD) | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | Baseline to 6 weeks (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Any SAEs During the Follow-up Phase | Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Days 42 to 180 |
| SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naga Chalasani, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Mayo Clinic |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. |
| FG001 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
|
| |||||||||||||||||||||
| Follow up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. |
| BG001 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | MELD Score Mean(SD) | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | The decrease in MELD score from baseline to Day 42 was -3.4 in the OCA arm, and -2.2 in the placebo arm with an overall P-Value of 0.6170. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (Day 42) |
|
6 months
Not provided
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 | Placebo | Placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naga Chalasani, MD | Indiana University School of Medicine | (317) 278-0414 | nchalasa@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2016 | Jun 14, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
Not provided
Not provided
| ID | Term |
|---|---|
| C464660 | obeticholic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 mg Obeticholic Acid (OCA) | Drug | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. |
|
|
Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). |
| Baseline to 180 days |
| Adverse Events (AEs) During the Treatment and Follow-up Phases | Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Baseline to 180 days |
| Change in MELD Score at 90 and 180 Days | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | Days 90 and 180 |
| Change in Child-Pugh Score at Day 42, 90 and 180 Days | The Child-Pugh score is a system for assessing the prognosis - including the required strength of treatment and necessity of liver transplant - of chronic liver disease, primarily cirrhosis. It provides a forecast of the increasing severity of your liver disease and your expected survival rate. The Child-Pugh score is determined by scoring five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The total Child-Pugh range is 5-15, with 15 being the most severe. | Days 42, 90 and 180 |
| Percentage of Participants Deceased at Day 42, 90 and 180 | Number of subjects deceased at day 42, 90, and 180. | Days 42, 90 and 180 |
| Rates of Hospitalization | Number of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Baseline to 180 days |
| Changes in Intestinal Inflammation | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Baseline to Day 180 |
| Changes in Serum Oxidative Stress. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Baseline to 180 days |
| Length of Hospital Stays | Baseline to 180 days |
| Changes in Bacterial Translocation | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Baseline to 180 days |
| Changes in Cytokines | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Baseline to 180 days |
| Changes in Activation of Innate Immunity | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Baseline to 180 days |
| Discontinuation Rate During the Treatment and Follow-up Phases | Baseline to 180 days |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| Virgina Commonwealth University | Richmond | Virginia | 23298 | United States |
| Physician Decision |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Death |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. |
|
|
|
| Primary | Incidence of Serious Adverse Events (SAEs) During the Treatment Phase | Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Subjects with SAEs not related to OCA | Posted | Number | Events | Baseline to 6 weeks (Day 42) |
|
|
|
| Primary | MELD Score Change From Baseline Mean(SD) | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks (Day 42) |
|
|
|
| Secondary | Any SAEs During the Follow-up Phase | Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Posted | Number | Events | Days 42 to 180 |
|
|
|
| Secondary | SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases | Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Posted | Number | Events | Baseline to 180 days |
|
|
|
| Secondary | Adverse Events (AEs) During the Treatment and Follow-up Phases | Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Posted | Number | Event | Baseline to 180 days |
|
|
|
| Secondary | Change in MELD Score at 90 and 180 Days | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. | Posted | Mean | Standard Deviation | units on a scale | Days 90 and 180 |
|
|
|
| Secondary | Change in Child-Pugh Score at Day 42, 90 and 180 Days | The Child-Pugh score is a system for assessing the prognosis - including the required strength of treatment and necessity of liver transplant - of chronic liver disease, primarily cirrhosis. It provides a forecast of the increasing severity of your liver disease and your expected survival rate. The Child-Pugh score is determined by scoring five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The total Child-Pugh range is 5-15, with 15 being the most severe. | Posted | Mean | Standard Deviation | units on a scale | Days 42, 90 and 180 |
|
|
|
| Secondary | Percentage of Participants Deceased at Day 42, 90 and 180 | Number of subjects deceased at day 42, 90, and 180. | Posted | Number | percentage of mortality | Days 42, 90 and 180 |
|
|
|
|
| Secondary | Rates of Hospitalization | Number of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite). | Posted | Number | Events | Baseline to 180 days |
|
|
|
| Secondary | Changes in Intestinal Inflammation | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Posted | Baseline to Day 180 |
|
|
| Secondary | Changes in Serum Oxidative Stress. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Posted | Baseline to 180 days |
|
|
| Secondary | Length of Hospital Stays | Posted | Mean | Standard Deviation | Days | Baseline to 180 days |
|
|
|
|
| Secondary | Changes in Bacterial Translocation | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Posted | Baseline to 180 days |
|
|
| Secondary | Changes in Cytokines | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Posted | Baseline to 180 days |
|
|
| Secondary | Changes in Activation of Innate Immunity | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured. | Posted | Baseline to 180 days |
|
|
| Secondary | Discontinuation Rate During the Treatment and Follow-up Phases | Posted | Number | Events | Baseline to 180 days |
|
|
|
| 1 |
| 11 |
| 5 |
| 11 |
| 9 |
| 11 |
| EG001 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks. | 0 | 8 | 6 | 8 | 8 | 8 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Blood electrolytes abnormal | Investigations | Systematic Assessment |
|
| Chronic gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | Systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Kidney injury molecule-1 | Investigations | Systematic Assessment |
|
| Major depression | Psychiatric disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Weigh Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Cholestatic pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Infections and infestations | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Faeces pale | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Jittery | General disorders | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lower urinary tract symptoms | Renal and urinary disorders | Systematic Assessment |
|
| Metabolic acidosis | Renal and urinary disorders | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neutrophil count increased | Investigations | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Penile swelling | Reproductive system and breast disorders | Systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pulmonary physical examination abnormal | Investigations | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Soft Tissue Mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Varices oesophageal | Vascular disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Possible |
|
| Probable |
|
| Definite |
|
| Possible |
|
| Probable |
|
| Definite |
|
| Possible |
|
| Probable |
|
| Definite |
|
| Possible |
|
| Probable |
|
| Definite |
|
| Day 180 |
|
| Day 180 |
|
| .3938 |
| Survival Anaylsis |
| 0 |
| 2-Sided |
| Superiority |
The type of statistical test is superiority. |
| Day 180 | Log Rank | .3938 | Survival Anaylsis | 0 | 2-Sided | Superiority | The type of statistical test is superiority. |
| Day 42 | Log Rank | .3938 | Survival Analysis | 0.09 | 2-Sided | Superiority | The type of statistical test is superiority. |
| Day 90 | Log Rank | .3938 | Survival Analysis | 0.09 | 2-Sided | Superiority | The type of statistical test is superiority. |
| Day 180 | Log Rank | .3938 | Survival Analysis | 0.09 | 2-Sided | Superiority | The type of statistical test is superiority. |
| Possible |
|
| Probable |
|
| Definite |
|