{"analyses":[{"ciLowerLimit":"1.051","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.946","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9890","pValueComment":"One-sided log-rank test was used.","paramType":"Hazard Ratio (HR)","paramValue":"1.43","statisticalComment":"Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.832","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.565","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7935","pValueComment":"One-sided log-rank test was used.","paramType":"Hazard Ratio (HR)","paramValue":"1.14","statisticalComment":"Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to limited number of events.","groupId":"OG000","lowerLimit":"13.5","upperLimit":"NA","value":"16.8"},{"comment":"The upper limit of 95% CI was not estimable due to limited number of events.","groupId":"OG001","lowerLimit":"14.8","upperLimit":"NA","value":"18.1"},{"comment":"The median and upper limit of 95% CI was not estimable due to limited number of events.","groupId":"OG002","lowerLimit":"18.2","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"331"},{"groupId":"OG002","value":"335"}],"units":"Participants"}],"description":"BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\\*min/mL) x (glomerular filtration rate\\[GFR\\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.","id":"OG000","title":"Chemotherapy Followed by Avelumab"},{"description":"In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \\[milligrams\\](mg) = Target AUC (mg\\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.","id":"OG001","title":"Chemotherapy + Avelumab Followed by Avelumab"},{"description":"In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \\[milligrams\\](mg) = Target AUC \\[milligrams\\*minute per milliliter\\] (mg\\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.","id":"OG002","title":"Chemotherapy Followed by Observation"}],"paramType":"MEDIAN","populationDescription":"The full analysis set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)","title":"Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)","type":"PRIMARY","unitOfMeasure":"months"}