{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"328"}],"units":"Participants"}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"328"}],"units":"Participants"}],"title":"Platelet Count Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"328"}],"units":"Participants"}],"title":"Lymphocyte Count Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"159"},{"groupId":"OG002","value":"156"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"328"}],"units":"Participants"}],"title":"Neutrophil Count Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"327"}],"units":"Participants"}],"title":"Creatinine Increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"321"},{"groupId":"OG001","value":"322"},{"groupId":"OG002","value":"326"}],"units":"Participants"}],"title":"Serum Amylase Increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"323"},{"groupId":"OG002","value":"325"}],"units":"Participants"}],"title":"Lipase Increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"327"}],"units":"Participants"}],"title":"ALT or AST"}],"denoms":[{"counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"329"},{"groupId":"OG002","value":"334"}],"units":"Participants"}],"description":"As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology \\[Anemia - Grade 3: hemoglobin \\<8.0 grams per deciliter (g/dL), \\<4.9 millimoles per liter (mmol/L), \\<80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:\\<50.0 to 25.0\\*10\\^9/Liters(L), Grade 4: \\<25.0\\*10\\^9/L; lymphocyte count decreased-Grade 3: \\<0.5-0.2\\*10\\^9/L, Grade 4: \\<0.2\\*10\\^9/L; neutrophil count decreased-Grade 3: \\<1.0 to 0.5\\*10\\^9 /L, Grade 4: \\<0.5\\*10\\^9/L\\]. Chemistry \\[creatinine increased-Grade 3: \\>3.0 to 6.0\\*upper limit of normal (ULN), Grade 4: \\>6.0\\*ULN; serum amylase increased, lipase increased-Grade 3: \\>2.0 - 5.0\\*ULN, Grade 4: \\>5.0\\*ULN\\]. Liver function \\[aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: \\>5.0 to 20.0\\*ULN, Grade 4: \\>20.0\\*ULN\\].","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":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set included all participants who received at least one dose of study drug. Here, 'Number analyzed' = Participants evaluable for this outcome measure for each specified row.","reportingStatus":"POSTED","timeFrame":"Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)","title":"Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03","type":"SECONDARY","unitOfMeasure":"Participants"}