{"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":"FG000","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":"FG001","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":"FG002","title":"Chemotherapy Followed by Observation"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"13"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death leading to discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Global deterioration of health status"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"No longer met eligibility criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Physician's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"10"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"15"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"332"},{"groupId":"FG001","numSubjects":"331"},{"groupId":"FG002","numSubjects":"335"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"328"},{"groupId":"FG001","numSubjects":"329"},{"groupId":"FG002","numSubjects":"334"}],"comment":"Participants who had received at least one dose of study drug","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"280"},{"groupId":"FG001","numSubjects":"294"},{"groupId":"FG002","numSubjects":"289"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"46"}],"type":"NOT COMPLETED"}],"title":"Chemotherapy Phase (CP)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death leading to discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Global deterioration of health status"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"No longer met eligibility criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"88"},{"groupId":"FG002","numSubjects":"0"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"114"},{"groupId":"FG001","numSubjects":"140"},{"groupId":"FG002","numSubjects":"0"}],"type":"Study terminated by sponsor"}],"milestones":[{"achievements":[{"comment":"Included participants without evidence of disease progression at the end of Chemotherapy phase.","groupId":"FG000","numSubjects":"267"},{"comment":"Included participants without evidence of disease progression at the end of Chemotherapy phase.","groupId":"FG001","numSubjects":"288"},{"comment":"After completing CP, participants moved to observation phase. MP was not applicable for this arm.","groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"266"},{"groupId":"FG001","numSubjects":"287"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Maintenance Phase (MP)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Death leading to discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"92"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"135"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"34"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Global deterioration of health status"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"After completing MP, participants moved to follow-up phase. OP was not applicable.","groupId":"FG000","numSubjects":"0"},{"comment":"After completing MP, participants moved to follow-up phase. OP was not applicable.","groupId":"FG001","numSubjects":"0"},{"comment":"Included participants without evidence of disease progression at the end of Chemotherapy phase.","groupId":"FG002","numSubjects":"284"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"282"}],"type":"NOT COMPLETED"}],"title":"Observation Phase (OP)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"4"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"138"},{"groupId":"FG002","numSubjects":"6"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"3"}],"type":"Death leading to discontinuation"}],"milestones":[{"achievements":[{"comment":"Participants not completing MP could also start this phase.","groupId":"FG000","numSubjects":"238"},{"comment":"Participants not completing MP could also start this phase.","groupId":"FG001","numSubjects":"263"},{"comment":"Participants not completing OP could also start this phase.","groupId":"FG002","numSubjects":"39"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"91"},{"groupId":"FG002","numSubjects":"20"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"172"},{"groupId":"FG002","numSubjects":"19"}],"type":"NOT COMPLETED"}],"title":"Follow-up Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"11"}],"type":"Death leading to discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"105"},{"groupId":"FG001","numSubjects":"80"},{"groupId":"FG002","numSubjects":"112"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Participants not completing follow-up phase could also start this phase.","groupId":"FG000","numSubjects":"139"},{"comment":"Participants not completing follow-up phase could also start this phase.","groupId":"FG001","numSubjects":"112"},{"comment":"Participants not completing follow-up could also start this phase.","groupId":"FG002","numSubjects":"135"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"139"},{"groupId":"FG001","numSubjects":"112"},{"groupId":"FG002","numSubjects":"135"}],"type":"NOT COMPLETED"}],"title":"Long-term Follow-up Phase"}]}