Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT00724893
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'No adverse events were collected for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '685', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \\[HCV-RNA\\]) at either of the follow-up evaluation time points (12 weeks \\[window 10-14 weeks\\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'PRIMARY', 'title': 'Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '660', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 weeks', 'description': 'This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population)'}, {'type': 'PRIMARY', 'title': 'Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '638', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population)'}, {'type': 'PRIMARY', 'title': 'Number of Participants Achieving SVR (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '468', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}, {'value': '1128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}, {'id': 'OG001', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '685', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with EVR evaluation at Treatment Week 12'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '660', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with EVR evaluation at Treatment Week 12'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '638', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with EVR evaluation at Treatment Week 12'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '679', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1037', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 2 (n=172)', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 3 (n=348)', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 4 (n=21)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 5 (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Genotype unknown (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population).'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'F0 (n=59)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'F1 (n=159)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'F2 (n=216)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'F3 (n=128)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'F4 (n=111)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Fibrosis stage unknown (n=629)', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'F0 (n=59)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'F1 (n=159)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'F2 (n=216)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'F3 (n=128)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'F4 (n=111)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Fibrosis stage unknown (n=629)', 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 2 (n=172)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 3 (n=348)', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 4 (n=21)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 5 (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Genotype missing (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Viral Load (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Viral load high (n=836)', 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}]}]}, {'title': 'Viral load low (n=109)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Viral load missing (n=357)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\\<100,000 Iu/mL).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Weight (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': '40 to <50 kg (n=21)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '50 to <64 kg (n=160)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': '64 to <75 kg (n=297)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}, {'title': '75 to <85 kg (n=283)', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}]}]}, {'title': '>85 kg (n=541)', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}, {'value': '629', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage F0', 'description': 'Participants with Fibrosis Stage F0'}, {'id': 'OG001', 'title': 'Stage F1', 'description': 'Participants with Fibrosis Stage F1'}, {'id': 'OG002', 'title': 'Stage F2', 'description': 'Participants with Fibrosis Stage F2'}, {'id': 'OG003', 'title': 'Stage F3', 'description': 'Participants with Fibrosis Stage F4'}, {'id': 'OG004', 'title': 'Stage F4', 'description': 'Participants with Fibrosis Stage F4'}, {'id': 'OG005', 'title': 'Unknown Stage', 'description': 'Participants with unknown Fibrosis Stage'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}]}, {'title': 'Genotype 2 (n=172)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '81', 'groupId': 'OG005'}]}]}, {'title': 'Genotype 3 (n=348)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '154', 'groupId': 'OG005'}]}]}, {'title': 'Genotype 4 (n=21)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Unknown Genotype (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '836', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Viral Load High', 'description': 'Participants with viral load xxxx'}, {'id': 'OG001', 'title': 'Viral Load Low', 'description': 'Participants with viral load xxxx'}, {'id': 'OG002', 'title': 'Viral Load Missing', 'description': 'Participants with viral load missing'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Genotype 2 (n=172)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'Genotype 3 (n=348)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Genotype 4 (n=21)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Unknown Genotype (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\\<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '283', 'groupId': 'OG003'}, {'value': '541', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '40 to <50 kg', 'description': 'Participants with weight 40 to \\<50 kg'}, {'id': 'OG001', 'title': '50 to <64 kg', 'description': 'Participants with weight 50 to \\<64 kg'}, {'id': 'OG002', 'title': '64 to <75 kg', 'description': 'Participants with weight 64 to \\<75 kg'}, {'id': 'OG003', 'title': '75 to <85 kg', 'description': 'Participants with weight 75 to \\<85 kg'}, {'id': 'OG004', 'title': '>85 kg', 'description': 'Participants with weight \\>85 kg'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '118', 'groupId': 'OG004'}]}]}, {'title': 'Genotype 2 (n=172)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}]}, {'title': 'Genotype 3 (n=348)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}]}, {'title': 'Genotype 4 (n=21)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Genotype unknown (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '780', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 10 to Week 14', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by EVR Type (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'EVR by ≥2 log reduction from baseline (n=78)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'EVR by HCV-RNA negative (n=389)', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}]}]}, {'title': 'EVR missing (n=6)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Gender (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Female (n=432)', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}, {'title': 'Male (n=870)', 'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Race (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Asian (n=78)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Black (n=18)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Caucasian (N=1110)', 'categories': [{'measurements': [{'value': '524', 'groupId': 'OG000'}]}]}, {'title': 'Hispanic (n=11)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=85)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'HIV positive (n=11)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'HIV negative (n=1075)', 'categories': [{'measurements': [{'value': '543', 'groupId': 'OG000'}]}]}, {'title': 'HIV status not done (n=216)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With End of Treatment (EOT) Response (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1, 4, and 6 (N=780)', 'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 2 and 3 (n=520)', 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000'}]}]}, {'title': 'Genotype missing (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '780', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1 (n=757)', 'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}]}]}, {'title': 'Genotypes 1,4, and 6 (n=780)', 'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Relapse Rate by HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1 (n=251)', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 2 (n=123)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 3 (n=217)', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 4 (n=5)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 6 (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population) and had EOT "yes" and valid EVR evaluation ; no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotypes 1, 4, and 6 (n=780)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 2 and 3 (n=520)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '690', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by Race (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Aboriginal peoples/Metis (n=10)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Asian (n=19)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Black (n=8)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Caucasian (n=343)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Hispanic (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=7)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by Race (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Aboriginal peoples/Metis (n=13)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Asian (n=54)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Black (n=20)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Caucasian (n=1002)', 'categories': [{'measurements': [{'value': '609', 'groupId': 'OG000'}]}]}, {'title': 'Hispanic (n=4)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=35)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Race (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Aboriginal peoples/Metis (n=13)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Asians (n=54)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Black (n=20)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Caucasian (n=1002)', 'categories': [{'measurements': [{'value': '407', 'groupId': 'OG000'}]}]}, {'title': 'Hispanic (n=4)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=35)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR Who Achieved SVR (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who achieved RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR Who Achieved SVR (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication and achieved EVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'F0 (n=28)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'F1 (n=30)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'F2 (n=49)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'F3 (n=14)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'F4 (n=27)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=206)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=34)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'F0 (n=66)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'F1 (n=144)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'F2 (n=212)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'F3 (99)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'F4 (n=110)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=463)', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=34)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'F0 (n=66)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'F1 (n=144)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'F2 (n=212)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'F3 (n=99)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'F4 (n=110)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=463)', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=34)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by Weight (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': '40 to <50 kg (n=3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '50-<64 kg (n=40)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': '64 to <75 kg (n=83)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '75 to <85 kg (n=86)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '>=85 kg (n=169)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Weight unknown (n=7)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by Weight (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': '40 to <50 kg (n=16)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '50 to <64 kg (n=127)', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': '64 to <75 kg (n=250)', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}]}]}, {'title': '75 to <85 kg (n=238)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': '>=85 kg (n=490)', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}]}]}, {'title': 'Weight unknown (n=7)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Weight (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': '40 to <50 kg (n=16)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '50 to <64 (n=127)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': '64 to <75 kg (n=250)', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': '75 to >85 kg (n=238)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': '>=85 kg (n=490)', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'Weight unknown (n=7)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1a (n=147)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 1b (n=56)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Genotype unknown (n=160)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Genotype mixed (n=11)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=14)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1a (n=176)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 1b (n=74)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Genotype unknown (n=850)', 'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000'}]}]}, {'title': 'Genotype mixed (n=14)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=14)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Genotype 1a (n=176)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Genotype 1b (n=74)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Genotype Unknown (n=850)', 'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}]}]}, {'title': 'Genotype mixed (n=14)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Could not be determined (n=14)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by Gender (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Female (n=122)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Male (n=266)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by Gender (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Female (n=346)', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}]}]}, {'title': 'Male (n=782)', 'categories': [{'measurements': [{'value': '463', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by Gender (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Female (n=346)', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Male (n=782)', 'categories': [{'measurements': [{'value': '301', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took at least one dose of study medication (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving RVR by HIV Status (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving EVR by HIV Status (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving SVR by HIV Status (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done.'}, {'type': 'SECONDARY', 'title': 'Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'classes': [{'title': 'Compliance < 80% (n=10)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Compliance ≥80% (n=304)', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'Compliance was defined as participants taking ≥80% versus \\<80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen \\[peginterferon\\] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the MAQ questionnaire during the study and achieved SVR'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}, {'id': 'FG001', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1302'}, {'groupId': 'FG001', 'numSubjects': '1128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '938'}, {'groupId': 'FG001', 'numSubjects': '670'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '458'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of virologic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '202'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Patient choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Geographic reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Substance abuse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Financial reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Assigned shorter treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Unknown, missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'BG000'}, {'value': '1128', 'groupId': 'BG001'}, {'value': '2430', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1 Participants', 'description': 'Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}, {'id': 'BG001', 'title': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<25 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '24 to < 40 years', 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}]}, {'title': '40 to < 55 yeats', 'categories': [{'measurements': [{'value': '783', 'groupId': 'BG000'}, {'value': '671', 'groupId': 'BG001'}, {'value': '1454', 'groupId': 'BG002'}]}]}, {'title': '>55 years', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '432', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '778', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '870', 'groupId': 'BG000'}, {'value': '782', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-25', 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \\[HCV-RNA\\]) at either of the follow-up evaluation time points (12 weeks \\[window 10-14 weeks\\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)', 'timeFrame': 'Up to 62 weeks', 'description': 'This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)', 'timeFrame': 'Up to 48 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment'}, {'measure': 'Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".'}, {'measure': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".'}, {'measure': 'The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".'}, {'measure': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)', 'timeFrame': 'Up to 62 weeks', 'description': 'Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).'}, {'measure': 'Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).'}, {'measure': 'Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Achieving SVR by Viral Load (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\\<100,000 Iu/mL).'}, {'measure': 'Number of Participants Achieving SVR by Weight (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas, and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\\<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Achieving EVR (Stage 1)', 'timeFrame': 'From Week 10 to Week 14', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by EVR Type (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Gender (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Race (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants With End of Treatment (EOT) Response (Stage 1)', 'timeFrame': 'Up to 48 weeks', 'description': 'EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".'}, {'measure': 'Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)', 'timeFrame': 'Up to 72 weeks', 'description': 'EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Relapse Rate by HCV Genotype (Stage 1)', 'timeFrame': 'Up to 48 weeks', 'description': 'The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)', 'timeFrame': 'Up to 48 weeks', 'description': 'An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.'}, {'measure': 'Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving RVR by Race (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR by Race (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Race (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving RVR Who Achieved SVR (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR Who Achieved SVR (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).'}, {'measure': 'Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).'}, {'measure': 'Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \\[scarred\\] and connects with other scarred areas , and F4 = severe damage \\[cirrhosis\\] and liver no longer functions properly).'}, {'measure': 'Number of Participants Achieving RVR by Weight (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR by Weight (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Weight (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.'}, {'measure': 'Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.'}, {'measure': 'Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.'}, {'measure': 'Number of Participants Achieving RVR by Gender (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR by Gender (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by Gender (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving RVR by HIV Status (Stage 2)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving EVR by HIV Status (Stage 2)', 'timeFrame': 'Week 12', 'description': 'EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Number of Participants Achieving SVR by HIV Status (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".'}, {'measure': 'Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)', 'timeFrame': 'Up to 72 weeks', 'description': 'Compliance was defined as participants taking ≥80% versus \\<80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen \\[peginterferon\\] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b \\[PegIFN-2b\\] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve patients with chronic hepatitis C\n* Adults (\\>18 years of age)\n* Prescribed Pegetron Redipen\n* Must meet all requirements for treatment with Pegetron Redipen\n* Must be able to obtain reimbursement of medication through private or provincial coverage\n\nExclusion Criteria:\n\n* Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \\[HBsAg\\] positive)\n* HIV antibody positive\n* Post liver transplant patients\n* Any other exclusion criteria as per the product Monograph'}, 'identificationModule': {'nctId': 'NCT00724893', 'briefTitle': 'Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program', 'orgStudyIdInfo': {'id': 'P04423'}, 'secondaryIdInfos': [{'id': 'MK-4031-267', 'type': 'OTHER', 'domain': 'Merck Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage 1 Participants', 'description': 'Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.', 'interventionNames': ['Biological: PegIFN-2b', 'Drug: Ribavirin']}, {'label': 'Stage 2 Participants', 'description': 'Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.', 'interventionNames': ['Biological: PegIFN-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'PegIFN-2b', 'type': 'BIOLOGICAL', 'otherNames': ['Pegetron®', 'Pegylated interferon alfa-2b', 'PegIntron', 'SCH 054031'], 'description': 'PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling', 'armGroupLabels': ['Stage 1 Participants', 'Stage 2 Participants']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['SCH 018908'], 'description': 'Ribavirin capsules administered orally. Dosing in accordance with approved labelling.', 'armGroupLabels': ['Stage 1 Participants', 'Stage 2 Participants']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}