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This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Hepatitis C | Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon Alfa-2a | Drug | Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response (SVR) | SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported. | At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks |
| Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR | RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
| PPV of Complete Early Viral Response (cEVR) on SVR | cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Odds Ratio (OR) for Impact of Age on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
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Inclusion Criteria:
- Diagnosis of chronic hepatitis C infection
Exclusion Criteria:
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Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatology Clinic Hepa | Tbilisi | 0159 | Georgia | |||
| Infectious Diseases, AIDS and Clinical Immunology Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon Alfa-2a and Ribavirin | Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon Alfa-2a and Ribavirin | Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants Achieving Sustained Virological Response (SVR) | SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported. | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks |
|
Baseline up to 96 weeks
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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 | Pegylated Interferon Alfa-2a and Ribavirin | Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin | Drug | Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling. |
|
|
| OR for Impact of Gender on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Body Weight on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Baseline Level of Fibrosis (kPa) on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Baseline Viral Load Count on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Overall Duration of Treatment on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Duration of Treatment After Achieving RVR on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Duration of Treatment After Achieving cEVR on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
| OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
| OR for Impact of Cumulative Doses of Ribavirin on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
| Tbilisi |
| 0160 |
| Georgia |
| Ltd Mrcheveli | Tbilisi | 0160 | Georgia |
| Good result at early stage of treatment |
|
| Withdrawal by Subject |
|
| Progression of the main disease |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR | RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
|
|
|
| Primary | PPV of Complete Early Viral Response (cEVR) on SVR | cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
|
|
|
| Secondary | Odds Ratio (OR) for Impact of Age on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Gender on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Body Weight on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Baseline Level of Fibrosis (kPa) on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Baseline Viral Load Count on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Overall Duration of Treatment on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Duration of Treatment After Achieving RVR on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Duration of Treatment After Achieving cEVR on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks) |
|
|
|
| Secondary | OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
|
|
|
| Secondary | OR for Impact of Cumulative Doses of Ribavirin on SVR | The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test). | Analysis population included all treated participants. | Posted | Number | 95% Confidence Interval | odds ratio | At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks |
|
|
|
| 17 |
| 516 |
| 256 |
| 516 |
| Anemia fourth degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia fourth degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia fourth degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Hypoalbuminemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Lingual bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Agitation | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Bilirubinemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thyrotoxicosis second degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia second degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia third degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia second degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Leukopenia third degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia second degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia third degree | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Liver enzymes incresed (ALT, AST other) | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| ST elevation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Paresthesia (numbness in hands) | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hemorrhoid varicose veins | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hyperemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Flushing | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Alopecia/hair loss | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Itching/pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Anal itching | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Herpes rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Left nostril furuncle | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Sweating - general | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dry mouth | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Toxidermia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Sty | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle weakness in legs | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Allergic reactions | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Autoimmune thyroiditis | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sexual potency impairment | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Flue-like syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sour throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper/epigastric pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Meteorism (flatulence) | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Adynamy | General disorders | MedDRA | Non-systematic Assessment |
|
| General weakness | General disorders | MedDRA | Non-systematic Assessment |
|
| Rigors | General disorders | MedDRA | Non-systematic Assessment |
|
| Sweating - general | General disorders | MedDRA | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Scalding during urination/urine scald | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Sexual potency impairment | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Weight decrease | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperthyroidism | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypothyroidism | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Emotional liability | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| 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 |