{"description":"Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.","eventGroups":[{"deathsNumAffected":34,"deathsNumAtRisk":328,"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":"EG000","otherNumAffected":320,"otherNumAtRisk":328,"seriousNumAffected":92,"seriousNumAtRisk":328,"title":"Chemotherapy Followed by Avelumab"},{"deathsNumAffected":31,"deathsNumAtRisk":329,"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":"EG001","otherNumAffected":325,"otherNumAtRisk":329,"seriousNumAffected":118,"seriousNumAtRisk":329,"title":"Chemotherapy + Avelumab Followed by Avelumab"},{"deathsNumAffected":20,"deathsNumAtRisk":334,"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":"EG002","otherNumAffected":317,"otherNumAtRisk":334,"seriousNumAffected":64,"seriousNumAtRisk":334,"title":"Chemotherapy Followed by Observation"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":328},{"groupId":"EG001","numAffected":17,"numAtRisk":329},{"groupId":"EG002","numAffected":18,"numAtRisk":334}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":328},{"groupId":"EG001","numAffected":68,"numAtRisk":329},{"groupId":"EG002","numAffected":58,"numAtRisk":334}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":328},{"groupId":"EG001","numAffected":39,"numAtRisk":329},{"groupId":"EG002","numAffected":24,"numAtRisk":334}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":328},{"groupId":"EG001","numAffected":33,"numAtRisk":329},{"groupId":"EG002","numAffected":20,"numAtRisk":334}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":167,"numAtRisk":328},{"groupId":"EG001","numAffected":169,"numAtRisk":329},{"groupId":"EG002","numAffected":177,"numAtRisk":334}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":148,"numAtRisk":328},{"groupId":"EG001","numAffected":151,"numAtRisk":329},{"groupId":"EG002","numAffected":140,"numAtRisk":334}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":328},{"groupId":"EG001","numAffected":18,"numAtRisk":329},{"groupId":"EG002","numAffected":15,"numAtRisk":334}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":328},{"groupId":"EG001","numAffected":85,"numAtRisk":329},{"groupId":"EG002","numAffected":57,"numAtRisk":334}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":328},{"groupId":"EG001","numAffected":28,"numAtRisk":329},{"groupId":"EG002","numAffected":21,"numAtRisk":334}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":328},{"groupId":"EG001","numAffected":46,"numAtRisk":329},{"groupId":"EG002","numAffected":22,"numAtRisk":334}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":328},{"groupId":"EG001","numAffected":36,"numAtRisk":329},{"groupId":"EG002","numAffected":31,"numAtRisk":334}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":113,"numAtRisk":328},{"groupId":"EG001","numAffected":100,"numAtRisk":329},{"groupId":"EG002","numAffected":95,"numAtRisk":334}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":328},{"groupId":"EG001","numAffected":55,"numAtRisk":329},{"groupId":"EG002","numAffected":22,"numAtRisk":334}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":328},{"groupId":"EG001","numAffected":7,"numAtRisk":329},{"groupId":"EG002","numAffected":8,"numAtRisk":334}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":328},{"groupId":"EG001","numAffected":55,"numAtRisk":329},{"groupId":"EG002","numAffected":37,"numAtRisk":334}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":328},{"groupId":"EG001","numAffected":101,"numAtRisk":329},{"groupId":"EG002","numAffected":63,"numAtRisk":334}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":328},{"groupId":"EG001","numAffected":38,"numAtRisk":329},{"groupId":"EG002","numAffected":28,"numAtRisk":334}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":328},{"groupId":"EG001","numAffected":20,"numAtRisk":329},{"groupId":"EG002","numAffected":18,"numAtRisk":334}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":328},{"groupId":"EG001","numAffected":24,"numAtRisk":329},{"groupId":"EG002","numAffected":22,"numAtRisk":334}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":328},{"groupId":"EG001","numAffected":47,"numAtRisk":329},{"groupId":"EG002","numAffected":29,"numAtRisk":334}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":328},{"groupId":"EG001","numAffected":12,"numAtRisk":329},{"groupId":"EG002","numAffected":12,"numAtRisk":334}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":123,"numAtRisk":328},{"groupId":"EG001","numAffected":115,"numAtRisk":329},{"groupId":"EG002","numAffected":110,"numAtRisk":334}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":328},{"groupId":"EG001","numAffected":18,"numAtRisk":329},{"groupId":"EG002","numAffected":11,"numAtRisk":334}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":328},{"groupId":"EG001","numAffected":51,"numAtRisk":329},{"groupId":"EG002","numAffected":30,"numAtRisk":334}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":328},{"groupId":"EG001","numAffected":18,"numAtRisk":329},{"groupId":"EG002","numAffected":16,"numAtRisk":334}],"term":"Hot flush"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":328},{"groupId":"EG001","numAffected":21,"numAtRisk":329},{"groupId":"EG002","numAffected":13,"numAtRisk":334}],"term":"Hypoaesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":328},{"groupId":"EG001","numAffected":27,"numAtRisk":329},{"groupId":"EG002","numAffected":20,"numAtRisk":334}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":328},{"groupId":"EG001","numAffected":42,"numAtRisk":329},{"groupId":"EG002","numAffected":27,"numAtRisk":334}],"term":"Hypomagnesaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":328},{"groupId":"EG001","numAffected":33,"numAtRisk":329},{"groupId":"EG002","numAffected":5,"numAtRisk":334}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":328},{"groupId":"EG001","numAffected":30,"numAtRisk":329},{"groupId":"EG002","numAffected":19,"numAtRisk":334}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":328},{"groupId":"EG001","numAffected":39,"numAtRisk":329},{"groupId":"EG002","numAffected":32,"numAtRisk":334}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v22.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":328},{"groupId":"EG001","numAffected":28,"numAtRisk":329},{"groupId":"EG002","numAffected":20,"numAtRisk":334}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 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