| Primary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT) | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, EOT (up to 48 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
| | | Title | Denominators | Categories |
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| Gender: Male | | | | Gender: Female | | | | Drug Addiction: Yes | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test. | Fisher Exact | | 0.647 | | | | | | | | | | | | | No | Superiority or Other | | | | The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test. |
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| Primary | Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 24 weeks after EOT (up to 72 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
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| Primary | Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, EOT (up to 48 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
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| Primary | Change From Baseline in SF-36 PCS at 24 Weeks After EOT | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 24 weeks after EOT (up to 72 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
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| Primary | Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, EOT (up to 48 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
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| Primary | Change From Baseline in SF-36 MCS at 24 Weeks After EOT | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). | Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 24 weeks after EOT (up to 72 weeks) | | | | ID | Title | Description |
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| OG000 | Chronic Hepatitis C Participants | Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics. |
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