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The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIntron | Experimental | PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up |
|
| Untreated Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2b (SCH 54031) | Biological | 0.5 µg/kg subcutaneously once weekly for 60 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Observation of the First Clinical Event Experienced by a Subject | Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Observation of the Disease Progression Experienced by a Subject | Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy. | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21419770 | Derived | Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17. |
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Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIntron | PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up |
| FG001 | Untreated Control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PegIntron | PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up |
| BG001 | Untreated Control | |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Time to Observation of the First Clinical Event Experienced by a Subject | Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation | Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses. | Posted | Number | Participants | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event |
|
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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 | PegIntron |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D005355 | Fibrosis |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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| Lost to Follow-up |
|
| Protocol-defined Clinical Event |
|
| Noncompliance With Protocol |
|
| Did Not Meet Protocol Eligibility |
|
| Administrative |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Untreated Control |
|
|
|
| Secondary | Time to Observation of the Disease Progression Experienced by a Subject | Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy. | Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses. | Posted | Number | Participants | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event |
|
|
|
|
| 93 |
| 311 |
| 290 |
| 311 |
| EG001 | Untreated Control | 74 | 315 | 260 | 315 |
| AUTOIMMUNE THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEARING IMPAIRED | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| CATARACT NUCLEAR | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIABETIC RETINOPATHY | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| RETINAL DETACHMENT | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ENTERITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTRIC VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HERNIAL EVENTRATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ILEITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| MALLORY-WEISS SYNDROME | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| OESOPHAGEAL ULCER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PERITONITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| RECTAL FISSURE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| BILIARY COLIC | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHRONIC HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC MASS | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| PORTAL HYPERTENSIVE GASTROPATHY | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
|
| ABDOMINAL WALL ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| BACTERAEMIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| BRONCHIECTASIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ENDOCARDITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ENDOCARDITIS BACTERIAL | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| FEBRILE INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| HAEMOPHILUS SEPSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| LUNG ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| MENINGITIS VIRAL | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| PSOAS ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| RECTAL ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| DISLOCATION OF VERTEBRA | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| INJURY | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| MENISCUS LESION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| NECK INJURY | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| POST PROCEDURAL FISTULA | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| POSTOPERATIVE FEVER | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| SKULL FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| WOUND SECRETION | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| ALPHA 1 FOETOPROTEIN INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| TRANSPLANT EVALUATION | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| DIABETES WITH HYPEROSMOLARITY | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| EXTRASKELETAL OSSIFICATION | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| BREAST CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| MALIGNANT PALATE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| OROPHARYNGEAL CANCER STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| SALIVARY GLAND ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| CEREBRAL CYST | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HYPERTONIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| MENINGORRHAGIA | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| BRADYPHRENIA | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| CALCULUS URINARY | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| BREAST CALCIFICATIONS | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| CYSTOCELE | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| MIDDLE LOBE SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| POST PROCEDURAL DRAINAGE | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| FEMORAL ARTERIAL STENOSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| HAEMATOMA | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| ILIAC ARTERY STENOSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| LYMPHOEDEMA | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| VARICOSE VEIN | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| VASCULITIS | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 11.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 11.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 11.0 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 11.0 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 11.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 11.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 11.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
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| HEPATOMEGALY | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| RENAL CYST | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| SPIDER NAEVUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
The investigator agrees to provide review copies to the sponsor 30 days prior to submission for publication or presentation. The sponsor shall have editorial rights and the right to review and comment on the data analysis and presentation. If the parties disagree, investigator agrees to meet with the sponsor's representatives for the purpose of making good faith efforts to discuss and resolve any such issues.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| >12 to 18 Months |
|
| >18 to 24 Months |
|
| >24 to 30 Months |
|
| >30 to 36 Months |
|
| >36 to 42 Months |
|
| >42 to 48 Months |
|
| >48 to 54 Months |
|
| >54 to 60 Months |
|
| Total Over Study |
|
| Superiority or Other |