Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-03-04 @ 9:58 PM
Study NCT ID:
NCT04956692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-03
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
Sponsor:
Organization:
Raw JSON
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This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 19 months', 'description': 'All-Cause Mortality includes all participants who enrolled. Adverse Events include all participants who received ≥1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.', 'otherNumAtRisk': 356, 'deathsNumAtRisk': 358, 'otherNumAffected': 331, 'seriousNumAtRisk': 356, 'deathsNumAffected': 118, 'seriousNumAffected': 132}, {'id': 'EG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 173, 'otherNumAffected': 160, 'seriousNumAtRisk': 172, 'deathsNumAffected': 48, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 237, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 118, 'numAffected': 100}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 218, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 107, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 137, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 62, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 70, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 77, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 141, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 64, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 39, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 56, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 46, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 60, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 37, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 63, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 81, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 41, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 74, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 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'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Connective tissue inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Soft tissue haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Delusional disorder, unspecified type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Immune-mediated nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '471.33', 'groupId': 'OG000', 'lowerLimit': '452.22', 'upperLimit': '491.26'}, {'value': '454.96', 'groupId': 'OG001', 'lowerLimit': '438.54', 'upperLimit': '471.99'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '1.04', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.10', 'pValueComment': 'The one-sided p-value non-inferiority boundary is 0.02', 'estimateComment': 'Numerator Arm A/Denominator Arm B', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.", 'nonInferiorityComment': 'The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.', 'unitOfMeasure': 'hr*µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1, and for whom a model-based assessment could be done.'}, {'type': 'PRIMARY', 'title': 'Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.93', 'groupId': 'OG000', 'lowerLimit': '53.05', 'upperLimit': '58.96'}, {'value': '30.25', 'groupId': 'OG001', 'lowerLimit': '27.93', 'upperLimit': '32.77'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '94', 'paramValue': '1.85', 'ciLowerLimit': '1.69', 'ciUpperLimit': '2.03', 'pValueComment': 'The one-sided p-value non-inferiority boundary is 0.03', 'estimateComment': 'Numerator Arm A/Denominator Arm B', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': "Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.", 'nonInferiorityComment': 'The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 6: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 6 model-based Ctrough is defined as the lowest concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6, as predicted by the pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data. Each cycle is 21 days.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1, and for whom a model-based assessment could be done.'}, {'type': 'SECONDARY', 'title': 'Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'The OR rate is defined as the percentage of participants who achieve a confirmed complete response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Cycle 1 Observed Ctrough of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.36', 'groupId': 'OG000', 'lowerLimit': '17.19', 'upperLimit': '19.61'}, {'value': '11.16', 'groupId': 'OG001', 'lowerLimit': '10.49', 'upperLimit': '11.88'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose Cycle 2 day 1. Each cycle is 21 days.', 'description': 'Cycle 1 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 1. Each cycle is 21 days.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1.'}, {'type': 'SECONDARY', 'title': 'Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '26.6'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '61.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 1 Cmax is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 1. Each cycle is 21 days.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 1.'}, {'type': 'SECONDARY', 'title': 'Cycle 6 AUC 0-3wks of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '1403.8', 'groupId': 'OG000', 'lowerLimit': '1342.0', 'upperLimit': '1468.5'}, {'value': '952.9', 'groupId': 'OG001', 'lowerLimit': '896.4', 'upperLimit': '1013.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 6 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 6. Each cycle is 21 days.', 'unitOfMeasure': 'hr*µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6, and for whom a model-based assessment could be done.'}, {'type': 'SECONDARY', 'title': 'Cycle 6 Cmax of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '62.2', 'upperLimit': '69.0'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '80.1', 'upperLimit': '91.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cmax in Cycle 6 is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 6. Each cycle is 21 days.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6.'}, {'type': 'SECONDARY', 'title': 'Cycle 6 Observed Ctrough of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'OG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.17', 'groupId': 'OG000', 'lowerLimit': '52.23', 'upperLimit': '62.58'}, {'value': '33.19', 'groupId': 'OG001', 'lowerLimit': '29.53', 'upperLimit': '37.30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose Cycle 7 day 1. Each cycle is 21 days.', 'description': 'Cycle 6 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6. Each cycle is 21 days.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized participants with at least 1 postdose sample in cycle 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 25 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue study treatment due to an AE will be presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 5 years', 'description': 'PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'OS is defined as the time from randomization to death due to any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 5 years', 'description': 'For participants who show confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}, {'type': 'SECONDARY', 'title': 'Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab', 'timeFrame': 'Up to approximately 26 months', 'description': 'ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'FG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '173'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Ongoing in Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '123'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'BG001', 'title': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-12', 'size': 961146, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-27T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 531}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-10-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2021-07-06', 'resultsFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-09', 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab', 'timeFrame': 'Cycle 1: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.'}, {'measure': 'Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab', 'timeFrame': 'Cycle 6: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 6 model-based Ctrough is defined as the lowest concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6, as predicted by the pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data. Each cycle is 21 days.'}], 'secondaryOutcomes': [{'measure': 'Objective Response (OR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'The OR rate is defined as the percentage of participants who achieve a confirmed complete response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.'}, {'measure': 'Cycle 1 Observed Ctrough of Pembrolizumab', 'timeFrame': 'Predose Cycle 2 day 1. Each cycle is 21 days.', 'description': 'Cycle 1 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 1. Each cycle is 21 days.'}, {'measure': 'Cycle 1 Maximum Concentration (Cmax) of Pembrolizumab', 'timeFrame': 'Cycle 1: predose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 2: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 1 Cmax is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 1. Each cycle is 21 days.'}, {'measure': 'Cycle 6 AUC 0-3wks of Pembrolizumab', 'timeFrame': 'Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cycle 6 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 6. Each cycle is 21 days.'}, {'measure': 'Cycle 6 Cmax of Pembrolizumab', 'timeFrame': 'Cycle 6: predose and postdose day 1; days 2, 3, 4, 5, 6, 7, 10, and 15. Cycle 7: predose day 1. Each cycle is 21 days.', 'description': 'Cmax in Cycle 6 is defined as the observed peak concentration of pembrolizumab in plasma over the dosing interval in Cycle 6. Each cycle is 21 days.'}, {'measure': 'Cycle 6 Observed Ctrough of Pembrolizumab', 'timeFrame': 'Predose Cycle 7 day 1. Each cycle is 21 days.', 'description': 'Cycle 6 observed Ctrough is defined as the lowest observed concentration of pembrolizumab in plasma at the end of the dosing interval in Cycle 6. Each cycle is 21 days.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 25 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue study treatment due to an AE will be presented.'}, {'measure': 'Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 5 years', 'description': 'PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 5 years', 'description': 'For participants who show confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.'}, {'measure': 'Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab', 'timeFrame': 'Up to approximately 26 months', 'description': 'ADA incidence will be assessed by analyzing the development of ADAs following administration of pembrolizumab SC and pembrolizumab IV.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death 1 (PD1, PD-1)', 'Programmed Cell Death-Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death-Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26224&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.\n\nParticipants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)\n* Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC\n* Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing\n* Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease\n* Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1\n* Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology\n* Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment\n* Has severe hypersensitivity to study intervention and/or any of its excipients\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection\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\n* Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible\n* Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (\\<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n* Received radiation therapy to the lung that is \\>30 Gray within 6 months of the first dose of study intervention\n* Is expected to require any other form of antineoplastic therapy while on study\n* For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period\n* For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation\n* Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease\n* Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention\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 the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention\n* Has had an allogenic tissue/solid organ transplant"}, 'identificationModule': {'nctId': 'NCT04956692', 'briefTitle': 'Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': '3475-A86'}, 'secondaryIdInfos': [{'id': 'MK-3475-A86', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2021210032', 'type': 'REGISTRY', 'domain': 'jRCT (Japan Registry of Clinical Trials)'}, {'id': '2023-508308-40', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1298-0215', 'type': 'OTHER', 'domain': 'UTN'}, {'id': '2020-002729-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.', 'interventionNames': ['Biological: Pembrolizumab SC', 'Drug: Paclitaxel', 'Drug: Nab-Paclitaxel', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy', 'description': 'Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \\~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.', 'interventionNames': ['Biological: Pembrolizumab IV', 'Drug: Paclitaxel', 'Drug: Nab-Paclitaxel', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'Pembrolizumab SC', 'type': 'BIOLOGICAL', 'description': 'SC injection', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy']}, {'name': 'Pembrolizumab IV', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®', 'SCH 900475'], 'description': 'IV injection', 'armGroupLabels': ['Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Nov-Onxol', 'Onxol', 'Paclitaxel Novaplus', 'Taxol'], 'description': 'IV injection', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}, {'name': 'Nab-Paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane', 'Nanoparticle albumin-bound paclitaxel'], 'description': 'IV infusion', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin', 'Paraplatin NovaPlus'], 'description': 'IV infusion', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Platinol-AQ'], 'description': 'IV infusion', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['LY231514', 'Alimta', 'Pemetrexed Disodium'], 'description': 'IV infusion', 'armGroupLabels': ['Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy', 'Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'St. Bernards Medical Center ( Site 0103)', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St Joseph Heritage Healthcare-Oncology ( Site 0102)', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Blood and Specialty Clinic ( Site 0105)', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'PIH Health Hematology Medical Oncology ( Site 0106)', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital ( Site 0017)', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health ( Site 0013)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology ( Site 0101)', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington ( Site 0099)', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St Luke's Hospital - Kansas City ( Site 0033)", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'St. Vincent Frontier Cancer Center ( Site 0058)', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center [Bronx, NY] ( Site 0040)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The University of Tennessee Medical Center ( Site 0050)', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology ( Site 0051)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oncology Consultants, PA ( Site 0052)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Millennium Physicians - Oncology ( Site 0097)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University ( Site 0056)', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '29308-065', 'city': 'Cachoeiro de Itapemirim', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)', 'geoPoint': {'lat': -20.84889, 'lon': -41.11278}}, {'zip': '99010-080', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Vicente de Paulo ( Site 0311)', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '89201260', 'city': 'Joinville', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}, {'zip': '15090-000', 'city': 'São José do 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