{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"12.7","value":"4.3"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.8","value":"2.1"},{"groupId":"OG002","lowerLimit":"1.5","upperLimit":"5.6","value":"3.0"},{"comment":"Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.","groupId":"OG003","lowerLimit":"1.4","upperLimit":"NA","value":"3.0"},{"groupId":"OG004","lowerLimit":"1.4","upperLimit":"5.6","value":"1.6"},{"comment":"Upper limit of Confidence Interval has not been achieved due to insufficient number of participants with events.","groupId":"OG005","lowerLimit":"2.8","upperLimit":"NA","value":"7.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"}],"units":"Participants"}],"description":"PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG000","title":"Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG001","title":"Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab"},{"description":"Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG002","title":"Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG003","title":"Phase II Part 2 - Cohort A - Anal Cancer - Avelumab"},{"description":"Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG004","title":"Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"OG005","title":"Phase II Part 2 - Cohort A - Genital Cancer - Avelumab"}],"paramType":"MEDIAN","populationDescription":"Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS)\n\nFor Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint.\n\nTherefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.","reportingStatus":"POSTED","timeFrame":"From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.","title":"Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification","type":"PRIMARY","unitOfMeasure":"Months"}