Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT01168856
Status:
TERMINATED
Last Update Posted:
2016-03-11
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Investigators were notified of the early termination of study in Jan2015 due to the completion of assessment for resistance monitoring arm and were encouraged to complete scheduled visits until Apr2015 for participants enrolled in SVR durability arm.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 36 Months', 'description': 'Only adverse events (AEs) and serious adverse events (SAEs) related to protocol defined blood sampling procedures were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.', 'otherNumAtRisk': 172, 'otherNumAffected': 1, 'seriousNumAtRisk': 172, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.', 'otherNumAtRisk': 552, 'otherNumAffected': 0, 'seriousNumAtRisk': 552, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'VENIPUNCTURE SITE BRUISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 552, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \\[IU/mL\\]).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.'}, {'type': 'PRIMARY', 'title': 'HCV RNA Levels in Resistance Monitoring Arm at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3922296', 'spread': '5111469', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.'}, {'type': 'PRIMARY', 'title': 'HCV RNA Levels in Resistance Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4369148', 'spread': '6803658', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.'}, {'type': 'PRIMARY', 'title': 'HCV RNA Levels in Resistance Monitoring Arm at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5016299', 'spread': '7235510', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.'}, {'type': 'PRIMARY', 'title': 'HCV RNA Levels in Resistance Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4955311', 'spread': '6595493', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.'}, {'type': 'PRIMARY', 'title': 'HCV RNA Levels in Resistance Monitoring Arm at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4830852', 'spread': '6621059', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.1', 'spread': '16.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in systolic blood pressure (units: millimeters of Mercury \\[Hg\\] \\[mmHg\\]) were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure in Resistance Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '126.0', 'spread': '16.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure in Resistance Monitoring Arm at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '126.9', 'spread': '15.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '127.1', 'spread': '14.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '130.3', 'spread': '17.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.8', 'spread': '10.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '10.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '9.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'spread': '9.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.3', 'spread': '9.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '9.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '10.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '12.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '10.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '10.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'Percentage of participants who received any anti-HCV medication during the monitoring period was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 36', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.'}, {'type': 'PRIMARY', 'title': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '896000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'timeFrame': 'Month 24', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.'}, {'type': 'PRIMARY', 'title': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'timeFrame': 'Month 36', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '126.8', 'spread': '16.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '127.4', 'spread': '16.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.0', 'spread': '15.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '130.1', 'spread': '16.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'spread': '10.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '10.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'spread': '10.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.'}, {'type': 'PRIMARY', 'title': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'spread': '10.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'spread': '10.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'spread': '9.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '10.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.'}, {'type': 'PRIMARY', 'title': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'spread': '11.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NP22660 \\[NCT01185860\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NP27946 \\[NCT01483742\\], NP28266 \\[NCT01628094\\]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'NP22660 Category 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NP22660 Category 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NP22660 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP27946 Category 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP27946 Category 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NP27946 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 1', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 1', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.\n\nResults are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With DNV Resistance Status-Clonal Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NP22660 \\[NCT01185860\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NP27946 \\[NCT01483742\\], NP28266 \\[NCT01628094\\]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'NP27946 Category 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP27946 Category 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NP27946 Category 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NP22660 Category 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NP22660 Category 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'NP22660 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'NV21075 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'NV22776 Category 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 1', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'PP25213 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'WV21913 Category 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NP27946 \\[NCT01483742\\], NP28266 \\[NCT01628094\\]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'TVR study NV22779 Category 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'TVR study NV22779 Category 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TVR study NV22779 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'TVR study NV22779 Category 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'TVR study NV22779 Category 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TVR study NV22779 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'BOC study NV22780 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 \\[NCT01628094\\]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'NP28266 Category 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With STV Resistance Status-Clonal Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.'}], 'classes': [{'title': 'NP28266 Category 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NP28266 Category 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.\n\nCategory 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 \\[NCT00869661\\], WV21913 \\[NCT01331850\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], NP28266 \\[NCT01628094\\]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.'}], 'classes': [{'title': 'NV20536', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NV27780', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'NP27946', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'NV27779', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'NP28266', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'WV21913', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'PP25213', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18', 'description': 'Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance monitoring population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}, {'id': 'FG001', 'title': 'Sustained Virological Response (SVR) Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '558'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '343'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Confirmed Quantifiable HCV RNA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant received anti-HCV treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '291'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants from following studies were enrolled: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\].', 'preAssignmentDetails': 'This study was terminated early and participants discontinued due to study termination were included under reason "unspecified" in the participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '552', 'groupId': 'BG001'}, {'value': '724', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Resistance Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.'}, {'id': 'BG001', 'title': 'SVR Durability Monitoring Arm', 'description': 'Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \\[NCT00869661\\], NV21075 \\[NCT00963885\\], WV21913 \\[NCT01331850\\], NV22621 \\[NCT01057667\\], NP22660 \\[NCT01185860\\], NV22688 \\[NCT01168856\\], NV22776 \\[NCT01220947\\], PP25213 \\[NCT01278134\\], NV27779 \\[NCT01482390\\], NV27780 \\[NCT01482403\\], NP27946 \\[NCT01483742\\], YV28218 \\[NCT01749150\\], NP28266 \\[NCT01628094\\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '8.48', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '10.79', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '10.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible population included all enrolled participants excluding participants with protocol violations.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Serum specimens collected from patients with partial viral response or viral load rebound of viral response to monitor for resistance mutations in viral RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 734}}, 'statusModule': {'whyStopped': 'This study was terminated due to the decrease in percentage of participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-12', 'studyFirstSubmitDate': '2010-07-15', 'resultsFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-12', 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3', 'timeFrame': 'Month 3', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \\[IU/mL\\]).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9', 'timeFrame': 'Month 9', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18', 'timeFrame': 'Month 18', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'HCV RNA Levels in Resistance Monitoring Arm at Month 3', 'timeFrame': 'Month 3', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'HCV RNA Levels in Resistance Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'HCV RNA Levels in Resistance Monitoring Arm at Month 9', 'timeFrame': 'Month 9', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'HCV RNA Levels in Resistance Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'HCV RNA Levels in Resistance Monitoring Arm at Month 18', 'timeFrame': 'Month 18', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in systolic blood pressure (units: millimeters of Mercury \\[Hg\\] \\[mmHg\\]) were reported at the discretion of principal investigator.'}, {'measure': 'Systolic Blood Pressure in Resistance Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Systolic Blood Pressure in Resistance Monitoring Arm at Month 9', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 3', 'timeFrame': 'Month 3', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 9', 'timeFrame': 'Month 9', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in Resistance Monitoring Arm at Month 18', 'timeFrame': 'Month 18', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm', 'timeFrame': 'Up to 18 months', 'description': 'Percentage of participants who received any anti-HCV medication during the monitoring period was reported.'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24', 'timeFrame': 'Month 24', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36', 'timeFrame': 'Month 36', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24', 'timeFrame': 'Month 24', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36', 'timeFrame': 'Month 36', 'description': 'Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).'}, {'measure': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6', 'timeFrame': 'Month 6', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12', 'timeFrame': 'Month 12', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24', 'timeFrame': 'Month 24', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36', 'timeFrame': 'Month 36', 'description': 'Any abnormalities in pulse rate were reported at the discretion of principal investigator.'}, {'measure': 'Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.\n\nResults are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.'}, {'measure': 'Number of Participants With DNV Resistance Status-Clonal Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.'}, {'measure': 'Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.'}, {'measure': 'Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.'}, {'measure': 'Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.'}, {'measure': 'Number of Participants With STV Resistance Status-Clonal Sequencing', 'timeFrame': 'Month 3-18', 'description': 'Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.\n\nCategory 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.\n\nCategory 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.\n\nCategory 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.\n\nCategory 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.'}, {'measure': 'Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688', 'timeFrame': 'Month 18', 'description': 'Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>/=18 years of age\n* chronic hepatitis C\n* participation in Roche DAA treatment protocol for CHC infection\n* DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response \\>/= 20 weeks after last dose of study medication in donor study\n\nExclusion Criteria:\n\n* For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA\n* For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study'}, 'identificationModule': {'nctId': 'NCT01168856', 'briefTitle': 'An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)', 'orgStudyIdInfo': {'id': 'NV22688'}, 'secondaryIdInfos': [{'id': '2009-016560-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037-1030', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103-8465', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United 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'07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78234', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98604', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2747', 'city': 'Kingswood', 'state': 'New South Wales', 'country': 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