Viewing Study NCT03765918

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Ignite Creation Date: 2025-12-25 @ 4:31 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
Study NCT ID: NCT03765918
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-08-20
First Post: 2018-11-06
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~66 months', 'description': 'All-Cause Mortality includes all randomized participants. Serious and Other AEs include the safety analysis population. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).", 'otherNumAtRisk': 361, 'deathsNumAtRisk': 363, 'otherNumAffected': 335, 'seriousNumAtRisk': 361, 'deathsNumAffected': 113, 'seriousNumAffected': 179}, {'id': 'EG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).", 'otherNumAtRisk': 315, 'deathsNumAtRisk': 351, 'otherNumAffected': 290, 'seriousNumAtRisk': 315, 'deathsNumAffected': 131, 'seriousNumAffected': 116}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 147, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 117, 'numAffected': 102}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 94, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 115, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 81, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 99, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 87, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 82, 'numAffected': 81}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 108, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 101, 'numAffected': 98}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 112, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 106, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 56, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 157, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 174, 'numAffected': 170}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 79, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 46, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 42, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 97, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 53, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 44, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 45, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 148, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 151, 'numAffected': 150}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 65, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 51, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 88, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 60, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 63, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 87, 'numAffected': 61}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 138, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 91, 'numAffected': 86}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 68, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 78, 'numAffected': 53}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 49, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 43, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 37, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 68, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 48, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 33, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 66, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 57, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 60, 'numAffected': 60}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 38, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 67, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pharyngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 53, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Laryngeal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Laryngeal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and 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thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oropharyngeal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tracheal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urticarial dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Inferior vena caval occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Major Pathological Response (mPR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '12.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.3', 'ciLowerLimit': '6.7', 'ciUpperLimit': '12.8', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'mPR Rate in Participants With PD-L1 CPS ≥10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '18.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '9.7', 'ciUpperLimit': '18.7', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'mPR Rate in Participants With PD-L1 CPS ≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '13.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '7.0', 'ciUpperLimit': '13.3', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Pathological Complete Response (pCR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '1.5', 'ciUpperLimit': '5.3', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'pCR Rate in Participants With PD-L1 CPS ≥10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '2.1', 'ciUpperLimit': '7.6', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'pCR Rate in Participants With PD-L1 CPS ≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '1.6', 'ciUpperLimit': '5.6', 'pValueComment': 'One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'statisticalMethod': 'Stratified Miettinen and Nurminen', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \\& Nurminen method stratified by primary tumor site and tumor stage.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '4.50'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '4.45'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.43'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.97', 'groupId': 'OG000', 'lowerLimit': '-3.19', 'upperLimit': '1.26'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.81', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '1.99'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-3.52', 'upperLimit': '1.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '3.69', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '6.34'}, {'value': '4.98', 'groupId': 'OG001', 'lowerLimit': '2.26', 'upperLimit': '7.70'}]}]}], 'analyses': [{'pValue': '0.4671', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '2.20', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000', 'lowerLimit': '-1.15', 'upperLimit': '5.40'}, {'value': '5.16', 'groupId': 'OG001', 'lowerLimit': '1.86', 'upperLimit': '8.45'}]}]}], 'analyses': [{'pValue': '0.1606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.03', 'ciLowerLimit': '-7.27', 'ciUpperLimit': '1.21', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '6.34'}, {'value': '5.03', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '7.83'}]}]}], 'analyses': [{'pValue': '0.4374', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.41', 'ciLowerLimit': '-4.96', 'ciUpperLimit': '2.15', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '7.23'}, {'value': '4.05', 'groupId': 'OG001', 'lowerLimit': '1.13', 'upperLimit': '6.97'}]}]}], 'analyses': [{'pValue': '0.8379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '4.13', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '7.33'}, {'value': '4.39', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '7.87'}]}]}], 'analyses': [{'pValue': '0.8643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '4.07', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '6.86'}, {'value': '4.29', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '7.29'}]}]}], 'analyses': [{'pValue': '0.8813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-4.12', 'ciUpperLimit': '3.54', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.09', 'groupId': 'OG000', 'lowerLimit': '-3.49', 'upperLimit': '-0.69'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.47', 'groupId': 'OG000', 'lowerLimit': '-4.25', 'upperLimit': '-0.69'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.06', 'groupId': 'OG000', 'lowerLimit': '-3.50', 'upperLimit': '-0.61'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.34', 'groupId': 'OG000', 'lowerLimit': '-4.92', 'upperLimit': '-1.76'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'groupId': 'OG000', 'lowerLimit': '-4.53', 'upperLimit': '-0.32'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.28', 'groupId': 'OG000', 'lowerLimit': '-4.92', 'upperLimit': '-1.63'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.48', 'groupId': 'OG000', 'lowerLimit': '-9.72', 'upperLimit': '-5.25'}, {'value': '-7.83', 'groupId': 'OG001', 'lowerLimit': '-10.15', 'upperLimit': '-5.50'}]}]}], 'analyses': [{'pValue': '0.8287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-2.76', 'ciUpperLimit': '3.45', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.22', 'groupId': 'OG000', 'lowerLimit': '-8.91', 'upperLimit': '-3.53'}, {'value': '-6.75', 'groupId': 'OG001', 'lowerLimit': '-9.47', 'upperLimit': '-4.03'}]}]}], 'analyses': [{'pValue': '0.7761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '4.18', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.42', 'groupId': 'OG000', 'lowerLimit': '-9.71', 'upperLimit': '-5.13'}, {'value': '-8.07', 'groupId': 'OG001', 'lowerLimit': '-10.46', 'upperLimit': '-5.68'}]}]}], 'analyses': [{'pValue': '0.6880', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '3.84', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.57', 'groupId': 'OG000', 'lowerLimit': '-8.91', 'upperLimit': '-4.22'}, {'value': '-5.12', 'groupId': 'OG001', 'lowerLimit': '-7.57', 'upperLimit': '-2.66'}]}]}], 'analyses': [{'pValue': '0.3858', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.45', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '1.83', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.15', 'groupId': 'OG000', 'lowerLimit': '-10.03', 'upperLimit': '-4.27'}, {'value': '-4.70', 'groupId': 'OG001', 'lowerLimit': '-7.74', 'upperLimit': '-1.66'}]}]}], 'analyses': [{'pValue': '0.2370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.45', 'ciLowerLimit': '-6.53', 'ciUpperLimit': '1.62', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.87', 'groupId': 'OG000', 'lowerLimit': '-9.32', 'upperLimit': '-4.43'}, {'value': '-5.11', 'groupId': 'OG001', 'lowerLimit': '-7.69', 'upperLimit': '-2.54'}]}]}], 'analyses': [{'pValue': '0.3138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.76', 'ciLowerLimit': '-5.20', 'ciUpperLimit': '1.67', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.36', 'groupId': 'OG000', 'lowerLimit': '-5.90', 'upperLimit': '-0.83'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.64', 'groupId': 'OG000', 'lowerLimit': '-9.73', 'upperLimit': '-3.55'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.98', 'groupId': 'OG000', 'lowerLimit': '-6.56', 'upperLimit': '-1.40'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.39', 'groupId': 'OG000', 'lowerLimit': '-4.78', 'upperLimit': '-0.01'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.06', 'groupId': 'OG000', 'lowerLimit': '-7.86', 'upperLimit': '-2.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.05', 'groupId': 'OG000', 'lowerLimit': '-5.47', 'upperLimit': '-0.63'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '7.58'}, {'value': '7.32', 'groupId': 'OG001', 'lowerLimit': '3.69', 'upperLimit': '10.95'}]}]}], 'analyses': [{'pValue': '0.1763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.28', 'ciLowerLimit': '-8.05', 'ciUpperLimit': '1.48', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '8.24'}, {'value': '5.06', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '9.46'}]}]}], 'analyses': [{'pValue': '0.6882', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-6.95', 'ciUpperLimit': '4.59', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '7.82'}, {'value': '6.72', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '10.45'}]}]}], 'analyses': [{'pValue': '0.3103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.52', 'ciLowerLimit': '-7.39', 'ciUpperLimit': '2.35', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '-2.07', 'upperLimit': '5.21'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '-1.77', 'upperLimit': '5.88'}]}]}], 'analyses': [{'pValue': '0.8475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-5.41', 'ciUpperLimit': '4.45', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-3.90', 'upperLimit': '4.90'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '-3.74', 'upperLimit': '5.59'}]}]}], 'analyses': [{'pValue': '0.8881', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-6.36', 'ciUpperLimit': '5.51', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '-2.46', 'upperLimit': '4.95'}, {'value': '1.47', 'groupId': 'OG001', 'lowerLimit': '-2.45', 'upperLimit': '5.38'}]}]}], 'analyses': [{'pValue': '0.9307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '4.78', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.31', 'groupId': 'OG000', 'lowerLimit': '-4.74', 'upperLimit': '0.12'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-4.06', 'groupId': 'OG000', 'lowerLimit': '-7.28', 'upperLimit': '-0.84'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.17', 'groupId': 'OG000', 'lowerLimit': '-4.61', 'upperLimit': '0.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-3.14', 'upperLimit': '1.67'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.84', 'groupId': 'OG000', 'lowerLimit': '-5.96', 'upperLimit': '0.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.76', 'groupId': 'OG000', 'lowerLimit': '-3.22', 'upperLimit': '1.70'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '9.80', 'groupId': 'OG000', 'lowerLimit': '6.47', 'upperLimit': '13.13'}, {'value': '8.50', 'groupId': 'OG001', 'lowerLimit': '5.04', 'upperLimit': '11.96'}]}]}], 'analyses': [{'pValue': '0.5752', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '5.85', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '8.44', 'groupId': 'OG000', 'lowerLimit': '4.47', 'upperLimit': '12.41'}, {'value': '7.46', 'groupId': 'OG001', 'lowerLimit': '3.36', 'upperLimit': '11.57'}]}]}], 'analyses': [{'pValue': '0.7196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '-4.38', 'ciUpperLimit': '6.34', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '10.01', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '13.39'}, {'value': '9.27', 'groupId': 'OG001', 'lowerLimit': '5.74', 'upperLimit': '12.80'}]}]}], 'analyses': [{'pValue': '0.7522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '5.37', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '5.54', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '9.27'}, {'value': '5.78', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '9.65'}]}]}], 'analyses': [{'pValue': '0.9255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-5.30', 'ciUpperLimit': '4.82', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '11.03'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '-0.81', 'upperLimit': '9.04'}]}]}], 'analyses': [{'pValue': '0.4926', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '8.60', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '6.10', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '9.92'}, {'value': '5.10', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '9.11'}]}]}], 'analyses': [{'pValue': '0.7087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '-4.23', 'ciUpperLimit': '6.21', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.80', 'groupId': 'OG000', 'lowerLimit': '-5.14', 'upperLimit': '-0.46'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.54', 'groupId': 'OG000', 'lowerLimit': '-8.50', 'upperLimit': '-2.59'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.25', 'groupId': 'OG000', 'lowerLimit': '-5.67', 'upperLimit': '-0.84'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.27', 'groupId': 'OG000', 'lowerLimit': '-8.68', 'upperLimit': '-3.87'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-9.14', 'groupId': 'OG000', 'lowerLimit': '-12.17', 'upperLimit': '-6.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-6.76', 'groupId': 'OG000', 'lowerLimit': '-9.23', 'upperLimit': '-4.28'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-12.16', 'groupId': 'OG000', 'lowerLimit': '-15.20', 'upperLimit': '-9.12'}, {'value': '-9.41', 'groupId': 'OG001', 'lowerLimit': '-12.52', 'upperLimit': '-6.29'}]}]}], 'analyses': [{'pValue': '0.1654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.75', 'ciLowerLimit': '-6.65', 'ciUpperLimit': '1.14', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-11.18', 'groupId': 'OG000', 'lowerLimit': '-14.80', 'upperLimit': '-7.55'}, {'value': '-11.43', 'groupId': 'OG001', 'lowerLimit': '-15.11', 'upperLimit': '-7.76'}]}]}], 'analyses': [{'pValue': '0.9117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-4.29', 'ciUpperLimit': '4.80', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-11.79', 'groupId': 'OG000', 'lowerLimit': '-14.91', 'upperLimit': '-8.67'}, {'value': '-9.57', 'groupId': 'OG001', 'lowerLimit': '-12.80', 'upperLimit': '-6.35'}]}]}], 'analyses': [{'pValue': '0.2808', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-6.25', 'ciUpperLimit': '1.82', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 25.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-14.82', 'groupId': 'OG000', 'lowerLimit': '-17.87', 'upperLimit': '-11.77'}, {'value': '-12.05', 'groupId': 'OG001', 'lowerLimit': '-15.21', 'upperLimit': '-8.89'}]}]}], 'analyses': [{'pValue': '0.1577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.77', 'ciLowerLimit': '-6.62', 'ciUpperLimit': '1.08', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-16.34', 'groupId': 'OG000', 'lowerLimit': '-20.12', 'upperLimit': '-12.56'}, {'value': '-13.53', 'groupId': 'OG001', 'lowerLimit': '-17.47', 'upperLimit': '-9.60'}]}]}], 'analyses': [{'pValue': '0.2485', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.81', 'ciLowerLimit': '-7.59', 'ciUpperLimit': '1.97', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '-15.03', 'groupId': 'OG000', 'lowerLimit': '-18.17', 'upperLimit': '-11.88'}, {'value': '-11.99', 'groupId': 'OG001', 'lowerLimit': '-15.26', 'upperLimit': '-8.72'}]}]}], 'analyses': [{'pValue': '0.1364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.03', 'ciLowerLimit': '-7.03', 'ciUpperLimit': '0.96', 'pValueComment': 'Two-sided p-value based on cLDA model.', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\\&N35 assessment data available for this outcome measure at Baseline and at Week 51.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants was presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'OS in Participants With PD-L1 CPS ≥10', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥10 was presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'OS in Participants With PD-L1 CPS ≥1', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥1 was presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to ~92 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to ~92 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study treatment due to an AE was reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'comment': 'NA = upper limit not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': 'NA'}, {'value': '30.4', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '50.1'}]}]}], 'analyses': [{'pValue': '0.00411', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.', 'nonInferiorityComment': "Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'PRIMARY', 'title': 'EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'comment': 'NA = upper limit not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': 'NA'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '51.5'}]}]}], 'analyses': [{'pValue': '0.00217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.88', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.', 'nonInferiorityComment': "HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}, {'type': 'PRIMARY', 'title': 'EFS in Participants With PD-L1 CPS ≥1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'comment': 'NA = upper limit not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': 'NA'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '41.9'}]}]}], 'analyses': [{'pValue': '0.00140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.89', 'statisticalMethod': 'Stratified Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.', 'nonInferiorityComment': "HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage."}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'FG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '316'}]}, {'type': 'Safety Analysis Population', 'comment': 'All participants who received ≥1 dose of study treatment: 1 participant in the SOC arm received neoadjuvant treatment, which was a protocol deviation, and this participant was continued in the Pembrolizumab + SOC arm in the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'Efficacy Analysis Population', 'comment': 'All randomized participants: 2 participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '351'}]}, {'type': 'Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 and 30) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 31-34) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 31-34) Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '351'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Participants Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '205'}]}]}], 'recruitmentDetails': 'Per protocol, patient-reported outcome (PRO) measures (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \\[EORTC QLQ-C30\\] Global Health Status \\[GHS\\]/Quality of Life \\[QoL\\]\\[Items 29 and 30\\], EORTC QLQ-C30 \\[Items 1-5\\], EORTC QLQ-Head and Neck Module 35 \\[H\\&N35\\] \\[Items 35-38\\], EORTC QLQ-H\\&N35 \\[Items 46, 53-54\\], and EORTC QLQ-H\\&N35 \\[Items 31-34\\] were reported separately for neoadjuvant and adjuvant treatment periods.', 'preAssignmentDetails': 'Two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations). One of the participants (who received one cycle of neoadjuvant treatment) was included in the SOC arm for the efficacy and safety analyses per protocol. The other participant (who received 2 cycles of neoadjuvant treatment) was included in the SOC arm for efficacy analysis and in the Pembrolizumab + SOC arm for the safety analysis per protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '714', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'BG001', 'title': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '286', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Tumor Site', 'classes': [{'categories': [{'title': 'Oropharynx', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Oral Cavity', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Larynx', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Hypopharynx', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The primary tumor site was categorized as tumor in oropharynx, oral cavity, larynx, and hypopharynx. The number of participants with tumor at each site at baseline was presented.', 'unitOfMeasure': 'Participants'}, {'title': 'Overall Cancer Staging at Baseline', 'classes': [{'categories': [{'title': 'III', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'IVA', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '528', 'groupId': 'BG002'}]}, {'title': 'IVB', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Joint Committee on Cancer 8th edition TNM stratified (PT=primary tumor \\[size \\& invasion of nearby tissue\\], LN=cancerous lymph nodes, Met=distant metastasis). Tumor site stages III: PT (fixated/limited invasion;\\>2-≥4cm+depth of invasion (DOI) \\>10mm/\\>4cm+DOI≥10mm); ipsilateral LN ≤3cm extranodal extension negative(ENE-) (except human papilloma virus \\[HPV\\]16+ oropharynx: invasive PT or LN\\>6cm); IVA: PT (moderate invasion-to adjacent structures\\[AS\\]);bilateral/ipsilateral/contralateral LN≤6cm ENE-; IVB: PT (advanced invasion-beyond AS) or LN\\>6cm ENE±. Higher numbers=more advanced cancer.', 'unitOfMeasure': 'Participants'}, {'title': 'Programmed Cell Death Ligand 1 (PD-L1) Status by Tumor Proportion Score (TPS)', 'classes': [{'categories': [{'title': 'TPS <50%', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}, {'title': 'TPS ≥50%', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry (IHC) assay using tumor tissue from a newly obtained biopsy. The number of participants with TPS \\<50 and TPS ≥50 at baseline was presented. Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.', 'unitOfMeasure': 'Participants'}, {'title': 'PD-L1 Status by Combined Positive Score (CPS; CPS10)', 'classes': [{'categories': [{'title': 'CPS <10', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'CPS ≥10', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The PD-L1 CPS status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS \\<10 and CPS ≥10 at baseline was presented. Participants with a CPS \\<10 were classified as PD-L1 negative and participants with a CPS ≥10 were classified as PD-L1 positive.', 'unitOfMeasure': 'Participants'}, {'title': 'PD-L1 Status by CPS (CPS1)', 'classes': [{'categories': [{'title': 'CPS <1', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'CPS ≥1', 'measurements': [{'value': '347', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The PD-L1 CPS status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS \\<1 and CPS ≥1 at baseline was presented. Participants with a CPS \\<1 were classified as PD-L1 negative and participants with a CPS ≥1 were classified as PD-L1 positive.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-29', 'size': 1360148, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-14T10:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 714}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2018-11-06', 'resultsFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-18', 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented.'}, {'measure': 'EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'EFS in Participants With PD-L1 CPS ≥1', 'timeFrame': 'Up to ~66 months', 'description': 'EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.'}], 'secondaryOutcomes': [{'measure': 'Major Pathological Response (mPR) Rate', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented.'}, {'measure': 'mPR Rate in Participants With PD-L1 CPS ≥10', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'mPR Rate in Participants With PD-L1 CPS ≥1', 'timeFrame': 'Up to ~66 months', 'description': 'mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Pathological Complete Response (pCR) Rate', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.'}, {'measure': 'pCR Rate in Participants With PD-L1 CPS ≥10', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'pCR Rate in Participants With PD-L1 CPS ≥1', 'timeFrame': 'Up to ~66 months', 'description': 'pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25', 'timeFrame': 'Baseline and Week 25', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51', 'timeFrame': 'Baseline and Week 51', 'description': 'EORTC QLQ-H\\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants was presented.'}, {'measure': 'OS in Participants With PD-L1 CPS ≥10', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥10 was presented.'}, {'measure': 'OS in Participants With PD-L1 CPS ≥1', 'timeFrame': 'Up to ~92 months', 'description': 'OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥1 was presented.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to ~92 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to ~92 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study treatment due to an AE was reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death 1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '40532178', 'type': 'DERIVED', 'citation': 'Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Brana I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18.'}], 'seeAlsoLinks': [{'url': 'http://merckclinicaltrials.com', 'label': 'Merck Clinical Trial Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26210&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.\n* Is eligible for primary surgery based on investigator decision and per local practice\n* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.\n* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy\n* Female participant that is not pregnant or breastfeeding\n* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\n* Has results from testing of HPV status for oropharyngeal cancer defined as p16\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization\n\nExclusion Criteria:\n\n* Has Stage T4B and/or N3 locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) and/or distant metastases\n* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)\n* Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.\n* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor\n* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start\n* Has received a live vaccine within 30 days prior to randomization\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy\n* Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis\n* Has Grade ≥2 audiometric hearing loss\n* Has Grade ≥2 neuropathy\n* Has Grade 3-4 bleeding due to the underlying malignancy\n* Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start\n* Has had previous allogeneic tissue/solid organ transplant\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \\[HCV\\] ribonucleic acid is detected).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study"}, 'identificationModule': {'nctId': 'NCT03765918', 'briefTitle': 'Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)', 'orgStudyIdInfo': {'id': '3475-689'}, 'secondaryIdInfos': [{'id': 'MK-3475-689', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-500254-41-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1274-2398', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2017-001139-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Standard of Care (SOC)', 'description': "Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).", 'interventionNames': ['Biological: Pembrolizumab 200 mg', 'Radiation: Radiotherapy 60 Gray', 'Radiation: Radiotherapy 66 Gray', 'Radiation: Radiotherapy 70 Gray', 'Drug: Cisplatin 100 mg/m^2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': "Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).", 'interventionNames': ['Radiation: Radiotherapy 60 Gray', 'Radiation: Radiotherapy 66 Gray', 'Radiation: Radiotherapy 70 Gray', 'Drug: Cisplatin 100 mg/m^2']}], 'interventions': [{'name': 'Pembrolizumab 200 mg', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®', 'MK-3475'], 'description': '200 mg administered IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Pembrolizumab + Standard of Care (SOC)']}, {'name': 'Radiotherapy 60 Gray', 'type': 'RADIATION', 'description': 'Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.', 'armGroupLabels': ['Pembrolizumab + Standard of Care (SOC)', 'Standard of Care (SOC)']}, {'name': 'Radiotherapy 66 Gray', 'type': 'RADIATION', 'description': 'High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.', 'armGroupLabels': ['Pembrolizumab + Standard of Care (SOC)', 'Standard of Care (SOC)']}, {'name': 'Radiotherapy 70 Gray', 'type': 'RADIATION', 'description': 'Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.', 'armGroupLabels': ['Pembrolizumab + Standard of Care (SOC)', 'Standard of Care (SOC)']}, {'name': 'Cisplatin 100 mg/m^2', 'type': 'DRUG', 'otherNames': ['Platinol®', 'Platinol-AQ®'], 'description': '100 mg/m\\^2 administered by IV infusion on Day 1 of each 21-day cycle', 'armGroupLabels': ['Pembrolizumab + Standard of Care (SOC)', 'Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores Cancer Center ( Site 1885)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Norris Comprehensive Cancer Center ( Site 1850)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92688', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 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