Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02580058
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609138', 'term': 'avelumab'}, {'id': 'C041277', 'term': '1-dodecylpyridoxal'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs (serious and non-serious) should be reported from the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months). Based on the cutoff: 13 July 2022.', 'description': 'The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. The mortality analysis set included all randomized participants. The AE and SAE analysis set included participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 173, 'seriousNumAtRisk': 187, 'deathsNumAffected': 122, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.', 'otherNumAtRisk': 182, 'deathsNumAtRisk': 182, 'otherNumAffected': 176, 'seriousNumAtRisk': 182, 'deathsNumAffected': 107, 'seriousNumAffected': 74}, {'id': 'EG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 167, 'seriousNumAtRisk': 177, 'deathsNumAffected': 116, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 68, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 131, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 77, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 58, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 52, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 68, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 88, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 147, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 78, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 45, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 29, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 61, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 69, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 67, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 48, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 47, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 69, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 58, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 61, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 57, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 45, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 66, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 131, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 117, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 125, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 73, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 63, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 65, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 58, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 30, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 54, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 84, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 33, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 22, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 70, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 41, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 69, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 45, 'numAffected': 37}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 28, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 15}, 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'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Obstructive nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vasculitic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Glucocorticoid deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Device related bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '14.1'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '18.7'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '15.5'}]}]}], 'analyses': [{'pValue': '0.8253', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.867', 'ciUpperLimit': '1.497', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '1-sided'}, {'pValue': '0.2082', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.672', 'ciUpperLimit': '1.179', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '1-sided'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).', 'description': 'OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '1.9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.1'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '>0.9999', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.310', 'ciUpperLimit': '2.160', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '1-sided'}, {'pValue': '0.0301', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.607', 'ciUpperLimit': '1.011', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '1-sided'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Based on BICR Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '7.5'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '19.0'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '8.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, \\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'ORR Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '9.6'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '24.9'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '14.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'PFS Based on Investigator Assessment According to RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '1.9'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.0'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.', 'unitOfMeasure': 'month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR) Based on BICR Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'comment': 'The upper limit of 95% confidence interval (CI) was not estimable due to the small number of events.', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': 'NA'}, {'value': '8.5', 'comment': 'The upper limit of 95% CI was not estimable due to the small number of events.', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': 'NA'}, {'value': '13.1', 'comment': 'The upper limit of 95% CI was not estimable due to the small number of events.', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \\[disappearance of all target lesions\\] or PR \\[\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.'}, {'type': 'SECONDARY', 'title': 'DR Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'comment': 'The upper limit of 95% CI was not estimable due to the small number of events.', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': 'NA'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '9.1'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '11.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \\[disappearance of all target lesions\\] or PR \\[\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.'}, {'type': 'SECONDARY', 'title': 'Disease Control (DC) Rate Based on BICR Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '40.2'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '64.6'}, {'value': '48.9', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': '56.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'DC Rate Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '41.3'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '54.3', 'upperLimit': '68.7'}, {'value': '54.7', 'groupId': 'OG002', 'lowerLimit': '47.4', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}]}, {'title': 'Treatment emergent SAEs', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': 'Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count decreased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Serum amylase increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Lipase increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who can be evaluated for CTCAE criteria for each parameter in each treatment group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': 'DBP Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '9.79', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '9.12', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '8.89', 'groupId': 'OG002'}]}]}, {'title': 'DBP Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '8.01', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '9.34', 'groupId': 'OG002'}]}]}, {'title': 'DBP Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '10.05', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '8.83', 'groupId': 'OG002'}]}]}, {'title': 'DBP Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '10.81', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '8.95', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '8.96', 'groupId': 'OG002'}]}]}, {'title': 'DBP Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '8.56', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '8.67', 'groupId': 'OG002'}]}]}, {'title': 'DBP End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '10.87', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '10.40', 'groupId': 'OG002'}]}]}, {'title': 'SBP Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '14.35', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '13.12', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '13.94', 'groupId': 'OG002'}]}]}, {'title': 'SBP Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '14.44', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '13.70', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '13.39', 'groupId': 'OG002'}]}]}, {'title': 'SBP Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '14.11', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '14.78', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '14.98', 'groupId': 'OG002'}]}]}, {'title': 'SBP Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '15.59', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '14.36', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '14.14', 'groupId': 'OG002'}]}]}, {'title': 'SBP Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '13.78', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '15.30', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '13.96', 'groupId': 'OG002'}]}]}, {'title': 'SBP End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '17.21', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '16.83', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '15.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '9.95', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '12.10', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '10.70', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '11.18', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '9.71', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '11.19', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '11.79', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11.78', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '11.14', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '11.44', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '10.41', 'groupId': 'OG002'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '13.70', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '14.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': 'QT increase from baseline >30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'QT increase from baseline >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'QT >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QT >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QT >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'QTcB increase from baseline >30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'QTcB increase from baseline >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'QTcB >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'QTcB >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'QTcB >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from baseline >30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'QTcF increase from baseline >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QTcF >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'QTcF >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'QTcF >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'QTcP increase from baseline >30 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'QTcP increase from baseline >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'QTcP >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'QTcP >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QTcP >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate <=50 bpm and decrease >= 20 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate >=120 bpm and increase >= 20 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'PR >=220 ms and increase from baseline >=20 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QRS >=120 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline \\>30 ms or 60 ms; absolute value \\> 450 ms, \\>480 ms and \\> 500 ms; 2) heart rate (HR): change from baseline \\>=20 bpm and absolute value \\<=50 bpm or \\>=120 bpm; 3) PR interval: absolute value \\>=220 ms and increase from baseline \\>=20 ms; 4) QRS: \\>= 120 ms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who had a at least 1 post-baseline ECG assessment performed."}, {'type': 'SECONDARY', 'title': 'Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'title': '>= 10 point decrease from baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '>= 15 point decrease from baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.', 'description': 'LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% \\>=10 points and \\>= 15 points decrease from baseline during the on-treatment period were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "'Number of Participants Analyzed' is based on number of participants in the safety analysis set with a baseline and a post-baseline assessment within each treatment group."}, {'type': 'SECONDARY', 'title': 'Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Biomarkers are measured only at screening.', 'description': 'PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on \\>=1% of tumor cells or \\>=5% of immune cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status."}, {'type': 'SECONDARY', 'title': 'Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Biomarkers are measured only at screening.', 'description': 'Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of \\>=1% CD8+ cells across the area of the tumor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'title': 'Deterioration', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}, {'title': 'Improved', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': 'Stable', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline."}, {'type': 'SECONDARY', 'title': 'Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median estimates of time to event, upper and lower limits of 95% CI were not estimable due to the small number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11.1', 'comment': 'The upper limit of 95% CI was not estimable due to the small number of events.', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': 'NA'}, {'value': '10.6', 'comment': 'The upper limit of 95% CI was not estimable due to the small number of events.', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.', 'description': "The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is based on the FAS. The FAS included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-VAS Score at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.6', 'spread': '20.56', 'groupId': 'OG000'}, {'value': '-11.2', 'spread': '19.79', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '22.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment/withdrawal visit', 'description': "The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale \\[EQ-VAS\\]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' represents number of participants in the FAS with an assessment at the visit or with at least a baseline and post-baseline assessment at visit."}, {'type': 'SECONDARY', 'title': 'Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '89', 'groupId': 'OG000'}, {'value': '23.19', 'spread': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110', 'ciLowerLimit': '95.4', 'ciUpperLimit': '126.7', 'groupDescription': 'Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At predose (0 H) on Cycle 2 Day 1', 'description': 'Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab.'}, {'type': 'SECONDARY', 'title': 'Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '231.6', 'spread': '43', 'groupId': 'OG000'}, {'value': '207.9', 'spread': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90', 'ciLowerLimit': '79.5', 'ciUpperLimit': '101.5', 'groupDescription': 'Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At postdose (end of infusion, 1H) on Cycle 2 Day 1', 'description': 'Cmax was defined as maximum observed serum concentration, and can be observed directly from data.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the LLQ for avelumab.'}, {'type': 'SECONDARY', 'title': 'Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '26810', 'spread': '14', 'groupId': 'OG000'}, {'value': '25850', 'spread': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96', 'ciLowerLimit': '87', 'ciUpperLimit': '106', 'groupDescription': 'PLD was the Reference treatment and Avelumab + PLD was the Test treatment.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'Cmax was defined as maximum observed serum concentration, and can be observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.'}, {'type': 'SECONDARY', 'title': 'Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '567600', 'spread': '11', 'groupId': 'OG000'}, {'value': '541700', 'spread': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95', 'ciLowerLimit': '88', 'ciUpperLimit': '104', 'groupDescription': 'PLD was the Reference treatment and Avelumab + PLD was the Test treatment.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From 0 through 24 hours postdose', 'description': 'AUC24 was defined as area under the concentration time profile from time zero to 24 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.'}, {'type': 'SECONDARY', 'title': 'Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2848000', 'spread': '20', 'groupId': 'OG000'}, {'value': '2571000', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90', 'ciLowerLimit': '76', 'ciUpperLimit': '107', 'groupDescription': 'PLD was the Reference treatment and Avelumab + PLD was the Test treatment.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'AUC336 was defined as area under the concentration time profile from time zero to 336 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.'}, {'type': 'SECONDARY', 'title': 'Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2043000', 'spread': '119', 'groupId': 'OG000'}, {'value': '2052000', 'spread': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (Test/Reference, %)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100', 'ciLowerLimit': '60', 'ciUpperLimit': '168', 'groupDescription': 'PLD was the Reference treatment and Avelumab + PLD was the Test treatment.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'All Participants', 'description': 'Total participants from the 2 arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was defined as participants with valid baseline ADA results and at least one valid post-baseline ADA result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Induced ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'All Participants', 'description': 'Total participants from the 2 arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was defined as participants with at least 1 valid post-baseline ADA results and without positive baseline ADA result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '342', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'OG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'OG002', 'title': 'All Participants', 'description': 'Total participants from the 2 arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set was defined as participants with at least 1 valid post-baseline ADA result and without positive baseline nAb result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'FG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'FG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This table included all randomized participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '190'}]}, {'type': 'Treated', 'comment': 'Participants received at least 1 dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'comment': 'Participants were considered completed when at least one drug of the combination is completed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '190'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'Global Deterioration of Health Status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'No Longer Meets Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '94'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Data reported based on last participant last visit (LPLV) date (12 July 2022).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '566', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Avelumab', 'description': 'Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.'}, {'id': 'BG001', 'title': 'Avelumab + PLD', 'description': 'Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.'}, {'id': 'BG002', 'title': 'Pegylated Liposomal Doxorubicin (PLD)', 'description': 'PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '349', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '10.26', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '10.05', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '10.64', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '10.32', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '566', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '416', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 3519515, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-20T18:15', 'hasProtocol': True}, {'date': '2017-12-13', 'size': 4149051, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-09T18:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2015-10-16', 'resultsFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-01', 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).', 'description': 'OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.'}, {'measure': 'Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'timeFrame': 'From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Based on BICR Assessment', 'timeFrame': 'Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, \\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.'}, {'measure': 'ORR Based on Investigator Assessment', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.'}, {'measure': 'PFS Based on Investigator Assessment According to RECIST Version 1.1', 'timeFrame': 'From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.', 'description': 'PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.'}, {'measure': 'Duration of Response (DR) Based on BICR Assessment', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \\[disappearance of all target lesions\\] or PR \\[\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.'}, {'measure': 'DR Based on Investigator Assessment', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \\[disappearance of all target lesions\\] or PR \\[\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.'}, {'measure': 'Disease Control (DC) Rate Based on BICR Assessment', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.'}, {'measure': 'DC Rate Based on Investigator Assessment', 'timeFrame': 'Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.', 'description': 'Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (\\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).'}, {'measure': 'Change From Baseline in Vital Signs - Blood Pressure', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.'}, {'measure': 'Change From Baseline in Vital Signs - Pulse Rate', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.', 'description': 'Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline \\>30 ms or 60 ms; absolute value \\> 450 ms, \\>480 ms and \\> 500 ms; 2) heart rate (HR): change from baseline \\>=20 bpm and absolute value \\<=50 bpm or \\>=120 bpm; 3) PR interval: absolute value \\>=220 ms and increase from baseline \\>=20 ms; 4) QRS: \\>= 120 ms.'}, {'measure': 'Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline', 'timeFrame': 'Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.', 'description': 'LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% \\>=10 points and \\>= 15 points decrease from baseline during the on-treatment period were summarized.'}, {'measure': 'Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS', 'timeFrame': 'Biomarkers are measured only at screening.', 'description': 'PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on \\>=1% of tumor cells or \\>=5% of immune cells.'}, {'measure': 'Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS', 'timeFrame': 'Biomarkers are measured only at screening.', 'description': 'Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of \\>=1% CD8+ cells across the area of the tumor.'}, {'measure': 'Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL', 'timeFrame': 'Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.'}, {'measure': 'Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28', 'timeFrame': 'From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.', 'description': "The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28."}, {'measure': 'Change From Baseline in EQ-VAS Score at End of Treatment', 'timeFrame': 'Baseline and end of treatment/withdrawal visit', 'description': "The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale \\[EQ-VAS\\]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS."}, {'measure': 'Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose', 'timeFrame': 'At predose (0 H) on Cycle 2 Day 1', 'description': 'Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.'}, {'measure': 'Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose', 'timeFrame': 'At postdose (end of infusion, 1H) on Cycle 2 Day 1', 'description': 'Cmax was defined as maximum observed serum concentration, and can be observed directly from data.'}, {'measure': 'Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'Cmax was defined as maximum observed serum concentration, and can be observed directly from data.'}, {'measure': 'Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'timeFrame': 'From 0 through 24 hours postdose', 'description': 'AUC24 was defined as area under the concentration time profile from time zero to 24 hours.'}, {'measure': 'Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'AUC336 was defined as area under the concentration time profile from time zero to 336 hours.'}, {'measure': 'Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose', 'timeFrame': 'From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose', 'description': 'AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).'}, {'measure': 'Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-boosted ADA was defined as a positive ADA result at baseline and the titer ≥ 8×baseline titer at least once after treatment with avelumab.'}, {'measure': 'Number of Participants With Treatment-Induced ADA', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-induced ADA was defined as participant who was ADA-negative at baseline and has at least one positive post-baseline ADA result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.'}, {'measure': 'Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)', 'timeFrame': 'At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab', 'description': 'Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.'}]}, 'conditionsModule': {'keywords': ['platinum resistant', 'platinum refractory'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '37665777', 'type': 'DERIVED', 'citation': 'Bonaca MP, Moslehi JJ, Ledermann JA, Michelon E, Wei C, Moran M, Monk BJ, Pujade-Lauraine E. Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With Avelumab, Pegylated Liposomal Doxorubicin, or Both. Oncologist. 2023 Oct 3;28(10):e977-e980. doi: 10.1093/oncolo/oyad213.'}, {'pmid': '37407274', 'type': 'DERIVED', 'citation': 'Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.'}, {'pmid': '34143970', 'type': 'DERIVED', 'citation': 'Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B9991009&StudyName=A%20Phase%203%2C%20Multicenter%2C%20Randomized%2C%20Open-label%20Study%20Of%20Avelumab%20%28msb0010718c%29%20Alone%20Or%20In%20Combination%20With%20Pegylated%20Liposomal%20Doxorubicin%20Versus%20Pegylated%20Liposomal%20Doxorubicin%20Alone%20In%20Patients%20With%20Platinum-resistant%2Frefractory%20Ovarian%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}, {'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B9991009&StudyName=A+Phase+3%2C+Multicenter%2C+Randomized%2C+Open-label+Study+Of+Avelumab+%28msb0010718c%29+Alone+Or+In+Combination+With+Pegylated+Liposomal+Doxorubicin+Versus+Pegylated+Liposomal+Doxorubicin+Alone+In+Patients+With+Platinum-resistant%2Frefractory+Ovarian+Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.\n* Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.\n* Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease\n* Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n\nMandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.\n\nExclusion Criteria:\n\n* Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).\n* Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).\n* Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.\n* Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.'}, 'identificationModule': {'nctId': 'NCT02580058', 'briefTitle': 'A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum 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