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The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW) | Experimental | PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up |
|
| Untreated Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2b (SCH 54031) | Biological | 0.5 µg/kg Weekly QW SC for 36 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). | Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline. | Baseline to up to Month-36 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) | Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Changes in liver inflammation defined as follows: Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23159770 | Derived | Poynard T, Bruix J, Schiff ER, Diago M, Berg T, Moreno-Otero R, Lyra AC, Carrilho F, Griffel LH, Boparai N, Jiang R, Burroughs M, Brass CA, Albrecht JK. Improved inflammatory activity with peginterferon alfa-2b maintenance therapy in non-cirrhotic prior non-responders: a randomized study. J Hepatol. 2013 Mar;58(3):452-9. doi: 10.1016/j.jhep.2012.11.001. Epub 2012 Nov 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW) | PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up |
| FG001 | Untreated Control | Participants were observed (no treatment given) for 36 months with 4-week follow-up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| |||||||||||||||||||||
| Follow-up Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW) | PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week 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 | Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). | Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline. | Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group. | Posted | Number | Participants | Baseline to up to Month-36 |
|
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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 | PEG-Intron |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | 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 |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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| Baseline to up to Month-36 |
| Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) | The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline. Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis). | Baseline to up to Month-36 |
| The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline | Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline. | Baseline to up to Month-36 |
| Mean Change in the METAVIR Activity Score (Using a Continuous Scale) | The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline. Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis). | Baseline to up to Month-36 |
| Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. | Definitions: Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline. | Baseline to up to Month-36 |
| Non-compliance with protocol |
|
| Lost to Follow-up |
|
| Administrative |
|
| Did not meet protocol eligibility |
|
| NOT COMPLETED |
|
|
Participants were observed (no treatment given) for 36 months with 4-week follow-up
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW) |
PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up |
| OG001 | Untreated Control | Participants were observed (no treatment given) for 36 months with 4-week follow-up |
|
|
| Secondary | Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) | Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Changes in liver inflammation defined as follows: Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline. | Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group. | Posted | Number | Participants | Baseline to up to Month-36 |
|
|
|
| Secondary | Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) | The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline. Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis). | ITT population who had both pre and up to Month-36 METAVIR fibrosis score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to up to Month-36 |
|
|
|
| Secondary | The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline | Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline. | Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group. | Posted | Number | Participants | Baseline to up to Month-36 |
|
|
|
| Secondary | Mean Change in the METAVIR Activity Score (Using a Continuous Scale) | The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline. Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis). | ITT population who had both pre and up to Month-36 METAVIR activity score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to up to Month-36 |
|
|
|
| Secondary | Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. | Definitions: Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis). Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline. | Population is ITT. Participants with missing Month-36 biopsy slides were classified as "no change", including 88 participants in the PEG-Intron group and 104 participants in the Observed group. | Posted | Number | Participants | Baseline to up to Month-36 |
|
|
|
| 53 |
| 270 |
| 234 |
| 270 |
| EG001 | Untreated Control | 31 | 270 | 200 | 270 |
| LYMPHOCYTOSIS | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| SPLENOMEGALY | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CARDIAC AMYLOIDOSIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| CORONARY OSTIAL STENOSIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| PERICARDITIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| DEAFNESS UNILATERAL | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| MENIERE'S DISEASE | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| RETROPERITONEAL FIBROSIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| SALIVARY GLAND CALCULUS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| VARICES OESOPHAGEAL | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| HERNIA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| CRYOGLOBULINAEMIA | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| FUNGAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| GASTROENTERITIS SALMONELLA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| BRAIN CONTUSION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| MENISCUS LESION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| NARCOTIC INTOXICATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| TYPE 1 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| PATELLOFEMORAL PAIN SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| PLICA SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| BENIGN NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| BREAST CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| BURKITT'S LYMPHOMA STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| METASTATIC RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| COMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEMIPLEGIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HYDROCEPHALUS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| INTRACRANIAL HAEMATOMA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| POLYNEUROPATHY | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| GLOMERULONEPHRITIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| BRONCHOPNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| COLD SWEAT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| PRURIGO | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| SUBSTANCE ABUSER | Social circumstances | MedDRA 12.1 | Systematic Assessment |
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| ARTERIAL THROMBOSIS LIMB | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| ARTERIOVENOUS FISTULA | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| ILIAC ARTERY STENOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| VASCULITIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| VENOUS THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 12.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| HEPATOMEGALY | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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No public presentation/publication of any interim results will be made by any principal investigator (PI) or any other member of the study staff without the Sponsor's prior written consent. The PI further agrees to provide to the sponsor 30 days prior to submission, review copies that report any results of the study. The sponsor shall have the right to review, comment, and edit. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues/disagreement.
| D006525 |
| Hepatitis, Viral, Human |
| 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 |
| D005355 | Fibrosis |
| Worsened |
|