Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT04607668
Status:
TERMINATED
Last Update Posted:
2024-11-26
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Slovakia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708352', 'term': 'trilaciclib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalinfo@g1therapeutics.com', 'phone': '+1 9192139835', 'title': 'Clinical Trial Info', 'organization': 'G1 Therapeutics, Inc'}, 'certainAgreement': {'otherDetails': 'The investigator will submit results communications for review by the sponsor at least 60 days prior to expected submission to the intended publisher or meeting committee. This review period may be shortened upon mutual consent. The sponsor may request modification of any publication, presentation or use by the investigator if such activity may jeopardize a patent application, an existing patent, or other proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks.', 'description': 'Analysis was performed on the Safety analysis set which included all randomized participants who received at least one dose of any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 155, 'seriousNumAtRisk': 159, 'deathsNumAffected': 49, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 159, 'seriousNumAtRisk': 160, 'deathsNumAffected': 26, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 61}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 92}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 118}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oral dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 35}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 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'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Aortic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Severe Neutropenia (DSN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '3.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.6', 'pValueComment': 'Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 to 4 (14-day cycles up to 56 days)', 'description': 'The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of \\< 0.5 × 10\\^9/L to the date of the first ANC value ≥ 0.5 × 10\\^9/L where no additional ANC values \\< 0.5 × 10\\^9/L were observed for the remainder of that cycle.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A Modified Intent-to-Treat (mITT) population was utilized in order to account for potential data integrity issues resulting from the war in Ukraine. The criteria for patients to be included in the mITT population consisted of all patients being randomized in countries other than Ukraine and all patients in Ukraine being randomized prior to 09 September 2021.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Severe Neutropenia (SN) During Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'aRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'statisticalMethod': 'modified Poisson model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Induction Period, cycles 1-12 (14-day cycles up to 168 days)', 'description': 'Severe neutropenia was defined as the absolute neutrophil count (ANC) laboratory value that met the Common Terminology Criteria for Adverse vents (CTCAE) criteria for ≥ Grade 4 toxicity (ie, ANC \\< 0.5 × 10\\^9/L in SI Unit)', 'unitOfMeasure': 'event per 100 cycles', 'reportingStatus': 'POSTED', 'populationDescription': 'A Modified Intent-to-Treat (mITT) population was utilized in order to account for potential data integrity issues resulting from the war in Ukraine. The criteria for patients to be included in the mITT population consisted of all patients being randomized in countries other than Ukraine and all patients in Ukraine being randomized prior to 09 September 2021.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Up to 52 months', 'description': 'Overall survival is defined as the time from the date of the first dose of study treatment to the date of death from any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Additional Myelopreservation Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on additional measures of the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by the number of SN events, granulocyte-colony stimulating factor (G-CSF) administration and febrile neutropenia (FN) adverse events (AE)', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell Lineage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 decreased hemoglobin laboratory values, RBC transfusions on or after Week 5, and erythropoiesis-stimulating agents (ESA) administration', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Platelet Lineage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on the platelet lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCR by measure of Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Multiple Lineage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on multiple lineages compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 hematologic lab values.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Standard of Care Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on standard of care dosing compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of all-cause dose reductions or cycle delays and relative dose intensity for FOLFOXIRI/bevacizumab', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Healthcare Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on healthcare utilization compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of hospitalizations and antibiotic use.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'Best overall response (BOR) will be determined using all visit responses prior to or on the date of (i) radiographic disease progression; (ii) withdrawal of consent to obtain scans; (iii) death; (iv) lost to follow-up; or (v) initiation of subsequent anti-cancer therapy other than the study drugs, whichever is earlier will be based on RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Response Evaluable (RE) population included those patients in the mITT population who received at least 1 dose of any study drug and had measurable (target) tumor lesion(s) at the baseline tumor assessment. The patients also had at least 1 post-baseline tumor assessment, discontinued treatment because of clinical progression prior to their first post-baseline tumor scan, or died due to disease progression prior to their first post-baseline tumor scan.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '50.3'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '48.5', 'upperLimit': '65.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \\<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference based on RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Response Evaluable (RE) population included those patients in the mITT population who received at least 1 dose of any study drug and had measurable (target) tumor lesion(s) at the baseline tumor assessment. The patients also had at least 1 post-baseline tumor assessment, discontinued treatment because of clinical progression prior to their first post-baseline tumor scan, or died due to disease progression prior to their first post-baseline tumor scan.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '10.2'}, {'value': '12.7', 'comment': 'The upper limit of the 95% Confidence Interval was not estimable due to insufficient participants with events.', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'DOR is the time between first objective response of CR or PR and the first date that progressive disease is objectively documented or death, whichever comes first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Response Evaluable (RE) population included those patients in the mITT population who received at least 1 dose of any study drug and had measurable (target) tumor lesion(s) at the baseline tumor assessment. The patients also had at least 1 post-baseline tumor assessment, discontinued treatment because of clinical progression prior to their first post-baseline tumor scan, or died due to disease progression prior to their first post-baseline tumor scan.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '11'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '18.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'PFS is defined as the time from the date of randomization until the date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population was utilized in order to account for potential data integrity issues resulting from the war in Ukraine. The criteria for patients to be included in the mITT population consisted of all patients being randomized in countries other than Ukraine and all patients in Ukraine being randomized prior to 09 September 2021.'}, {'type': 'SECONDARY', 'title': 'Quality of Life/ Effects on Chemotherapy-Induced Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'timeFrame': 'Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC, as measured by Time To First Confirmed Deterioration of Fatigue (TTCD-fatigue) during Induction, as measured by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination, data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reported Adverse Events to Measure Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'OG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'classes': [{'title': 'Number of patients with any AE', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with any AE of CTCAE Grade ≥ 3', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with any AE of CTCAE Grade ≥ 4', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with any study drug-related AE', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Trilaciclib/Placebo-Related AE', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Fluorouracil-related AE', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Leucovorin-related AE', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Oxaliplatin-related AE', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Irinotecan-related AE', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Bevacizumab-related AE', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Patients with any serious AE', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Patients with AE leading to discontinuation of any study drug', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Leading to trilaciclib/placebo discontinuation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Leading to fluorouracil discontinuation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Leading to leucovorin discontinuation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Leading to oxaliplatin discontinuation', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Leading to irinotecan discontinuation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Leading to bevacizumab discontinuation', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Patients with trilaciclib/placebo-related AE leading to discontinuation of any study drug', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Patients with AE leading to death', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Patients with AESI for trilaciclib', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'To assess the safety and tolerability of trilaciclib compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of occurrence and severity of AEs by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, changes in laboratory parameters, vital signs and electrocardiogram (ECG) parameters, grade 3 or 4 abnormalities in chemistry laboratory parameters, and study treatment discontinuation due to AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all randomized patients who received at least 1 dose of any study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'FG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All patients in the ITT population.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'Patients With ≥ 1 Dose of Study Drug, n (%)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '162'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Other, unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '89 study centers in 8 countries consented at least 1 participant. The first participant was enrolled on January 6, 2021 and the last visit of the last participant occurred on March 31, 2023.', 'preAssignmentDetails': 'A total of 458 participants were screened in this study. 326 participants were randomized in a double-blind manner to receive either trilaciclib or placebo, administered on Days 1 and 2 of each cycle of FOLFOXIRI and bevacizumab therapy. A total of 319 participants received at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trilaciclib + FOLFOXIRI/Bevacizumab', 'description': 'During Induction the following study drugs were administered on Day 1:\n\nTrilaciclib - IV infusion prior to chemotherapy Irinotecan- IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil (5-FU) - continuous infusion (CI) over 46-48 hours beginning on Day 1, Bevacizumab - IV\n\nThe Induction Day 1 administration of trilaciclib was repeated on Induction Day 2.\n\nFollowing completion of Induction, patients continued in Maintenance, where they continued to receive trilaciclib per randomization allocation. Trilaciclib was administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.'}, {'id': 'BG001', 'title': 'Placebo + FOLFOXIRI/Bevacizumab', 'description': 'The subjects in the placebo arm followed the same schedule as the trilaciclib arm, but received placebo instead of trilaciclib\n\nPlacebo: dextrose 5% in water or normal saline (sodium chloride solution 0.9%)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '11.80', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '10.60', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '11.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Information presented is based on overall enrollment into the study and constitutes the ITT population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-15', 'size': 6674599, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-29T10:14', 'hasProtocol': True}, {'date': '2023-01-09', 'size': 1283924, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-29T10:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blinded Trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'whyStopped': 'The Sponsor made the decision to terminate the study and complete the final analysis for available data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2020-10-20', 'resultsFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Severe Neutropenia (DSN)', 'timeFrame': 'Cycles 1 to 4 (14-day cycles up to 56 days)', 'description': 'The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of \\< 0.5 × 10\\^9/L to the date of the first ANC value ≥ 0.5 × 10\\^9/L where no additional ANC values \\< 0.5 × 10\\^9/L were observed for the remainder of that cycle.'}, {'measure': 'Occurrence of Severe Neutropenia (SN) During Induction', 'timeFrame': 'Induction Period, cycles 1-12 (14-day cycles up to 168 days)', 'description': 'Severe neutropenia was defined as the absolute neutrophil count (ANC) laboratory value that met the Common Terminology Criteria for Adverse vents (CTCAE) criteria for ≥ Grade 4 toxicity (ie, ANC \\< 0.5 × 10\\^9/L in SI Unit)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 52 months', 'description': 'Overall survival is defined as the time from the date of the first dose of study treatment to the date of death from any cause.'}, {'measure': 'Additional Myelopreservation Measures', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on additional measures of the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by the number of SN events, granulocyte-colony stimulating factor (G-CSF) administration and febrile neutropenia (FN) adverse events (AE)'}, {'measure': 'Red Blood Cell Lineage', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 decreased hemoglobin laboratory values, RBC transfusions on or after Week 5, and erythropoiesis-stimulating agents (ESA) administration'}, {'measure': 'Platelet Lineage', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on the platelet lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCR by measure of Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions.'}, {'measure': 'Multiple Lineage', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on multiple lineages compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 hematologic lab values.'}, {'measure': 'Standard of Care Dosing', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on standard of care dosing compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of all-cause dose reductions or cycle delays and relative dose intensity for FOLFOXIRI/bevacizumab'}, {'measure': 'Healthcare Utilization', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on healthcare utilization compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of hospitalizations and antibiotic use.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'Best overall response (BOR) will be determined using all visit responses prior to or on the date of (i) radiographic disease progression; (ii) withdrawal of consent to obtain scans; (iii) death; (iv) lost to follow-up; or (v) initiation of subsequent anti-cancer therapy other than the study drugs, whichever is earlier will be based on RECIST v1.1.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to \\<10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference based on RECIST v1.1.'}, {'measure': 'Duration of Objective Response (DOR)', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'DOR is the time between first objective response of CR or PR and the first date that progressive disease is objectively documented or death, whichever comes first.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'PFS is defined as the time from the date of randomization until the date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first.'}, {'measure': 'Quality of Life/ Effects on Chemotherapy-Induced Fatigue', 'timeFrame': 'Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab', 'description': 'To assess the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC, as measured by Time To First Confirmed Deterioration of Fatigue (TTCD-fatigue) during Induction, as measured by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue).'}, {'measure': 'Number of Participants With Reported Adverse Events to Measure Safety and Tolerability', 'timeFrame': 'Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks', 'description': 'To assess the safety and tolerability of trilaciclib compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of occurrence and severity of AEs by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, changes in laboratory parameters, vital signs and electrocardiogram (ECG) parameters, grade 3 or 4 abnormalities in chemistry laboratory parameters, and study treatment discontinuation due to AEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'mCRC', 'colon', 'chemotherapy-induced myelosuppression', 'chemotherapy-induced neutropenia', 'chemotherapy-induced anemia', 'CDK 4/6 inhibitor', 'trilaciclib', 'FOLFOXIRI', 'bevacizumab', 'myelosuppression', 'cyclin-dependent kinase 4/6 inhibitor', 'myelopreservation', 'rectum', 'Preserve', 'PRESERVE 1'], 'conditions': ['Colorectal Cancer Metastatic', 'Myelosuppression-Adult', 'Chemotherapeutic Toxicity']}, 'referencesModule': {'references': [{'pmid': '39579142', 'type': 'DERIVED', 'citation': 'Lenz HJ, Liu T, Chen EY, Horvath Z, Bondarenko I, Danielewicz I, Ghidini M, Garcia-Alfonso P, Jones R, Aapro M, Zhang Y, Wang J, Wang W, Adeleye J, Beelen A, Hubbard J. Trilaciclib prior to FOLFOXIRI/bevacizumab for patients with untreated metastatic colorectal cancer: phase 3 PRESERVE 1 trial. JNCI Cancer Spectr. 2025 Jan 3;9(1):pkae116. doi: 10.1093/jncics/pkae116.'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.', 'detailedDescription': 'Patients were randomly assigned (1:1) to receive placebo or trilaciclib on Days 1 and 2 administered intravenously (IV) prior to FOLFOXIRI/bevacizumab in 14-day cycles for up to 12 cycles (Induction).\n\nFollowing completion of Induction, patients continued in Maintenance, where they received trilaciclib or placebo per randomization allocation at study entry. Trilaciclib/placebo will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction. The patient continued to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first. Treatment cycles occurred consecutively without interruption, except when necessary to manage toxicities or for administrative reasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of signing the informed consent. Patients \\> 70 years of age must have a G8 Health State Screening Tool (geriatric screening tool) score \\> 14.\n2. Proficient mismatch repair/microsatellite stable (pMMR/MSS), histologically or cytologically-confirmed adenocarcinoma of the colon or rectum. Patients with any BRAF or KRAS mutation status (wild type or mutant) are eligible. If historical pMMR/MSS and/or BRAF V600E mutational status are not known, a tumor specimen (archival or fresh biopsy) must be sent for testing and results must be available at the time of randomization in interactive web response system (IWRS). If testing cannot be completed using a standard clinical assay performed institutionally/locally, the tumor specimen may be sent to the Sponsor's designated central laboratory for analysis; only historical KRAS mutational status will be collected (ie, no testing required prior to study entry). Note: Any sample sent for MSS/BRAF analysis will be in addition to that required per Inclusion Criterion 5.\n3. Unresectable and measurable or metastatic colorectal cancer per RECIST v1.1\n4. ECOG performance status of 0 to 1\n5. A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting pMMR/MSS mCRC must be confirmed to be available to send to the Sponsor for planned retrospective biomarker analyses (tissue requirements are provided in the associated laboratory manual).\n6. Hemoglobin ≥ 9.0 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of trilaciclib/placebo\n7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9 /L\n8. Platelet count ≥ 100 × 10\\^9 /L\n9. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73m\\^2\n10. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n11. AST, ALT, and alkaline phosphatase ≤ 3 × ULN for patients without liver or bone metastases; AST, ALT and alkaline phosphatase ≤ 5 × ULN in the presence of liver metastases; AST and ALT ≤ 3 x ULN and alkaline phosphatase ≤ 5 × ULN in the presence of bone metastases\n12. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia)\n13. Urine dipstick protein \\< 2+. If ≥ 2+ at Screening, then a 24-hour urine collection must be done to demonstrate ≤ 1 g of protein/24 hours\n14. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Please see Section 17.4 for detailed instructions on methods of contraception requirements.\n15. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for mCRC. Patients who received adjuvant/neoadjuvant therapy (ie, treatment with curative intent) for colorectal cancer are eligible if it has been ≥ 6 months between the last dose of systemic chemotherapy and the date of informed consent.\n2. Any radiotherapy, chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or PSA persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.\n3. Receipt of any low-dose systemic chemotherapeutic agent (e.g., low-dose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo.\n4. Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo).\n5. QTcF interval \\> 450 msec (males) or \\> 470 msec (females) at screening. For patients with ventricular pacemakers, QTcF \\> 500 msec.\n6. Personal or family history of long QT syndrome\n7. Symptomatic peripheral neuropathy\n8. History of interstitial lung disease (ILD)\n9. Uncontrolled hypertension (blood pressure ≥ 150/90mm Hg)\n10. Clinically significant (i.e., active) cardiovascular disease at the time of signing the informed consent; for example cerebrovascular accidents (≤ 6 months before the first dose of trilaciclib/placebo), myocardial infarction (≤ 6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrhythmia requiring medication, or uncontrolled symptomatic congestive heart failure \\[Class II or higher as defined by the New York Heart Association \\[NYHA\\] functional classification system\\])\n11. Serious, non-healing wound, ulcer, or bone fracture\n12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.\n13. Known serious active infection (e.g., human immunodeficiency virus \\[HIV\\], hepatitis B or C, tuberculosis, etc.)\n14. Known Gilbert's Syndrome or homozygous for the UGT1A1\\*28 allele. UGT1A1 genotyping is not required for this study.\n15. Chronic inflammatory bowel disease and/or active intestinal obstruction. Patients should not be treated until the intestinal obstruction has resolved.\n16. Previous history of significant/severe hemorrhage, within 1 month before randomization. History of previous abdominal fistula or gastrointestinal perforation within 6 months before randomization\n17. Known history of bleeding diathesis or coagulopathy\n18. INR \\> 1.5 within 14 days prior to starting study treatment. EXEMPTION: patients on full anticoagulation must have an in-range INR (usually between 2 to 3) if INR is used for monitoring. Any anticoagulation therapy must be at stable dosing prior to enrollment.\n19. Ongoing or anticipated treatment with potent cytochrome inhibitors CYP450 3A4 (such as ketoconazole) or inducers (such as rifampicin, carbamazepine, phenobarbital, phenytoin or St. John's wort). Irinotecan should not be delivered concurrently.\n20. Patients with ongoing or anticipated treatment with sorivudine or its chemically related analogues, such as brivudine.\n21. Chronic, daily treatment with high-dose aspirin (\\> 325 mg/day)\n22. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation\n23. Receipt of any live attenuated vaccines within 4 weeks prior to first dose of study treatment\n24. Known hypersensitivity to any of the drugs used in this study\n25. Pregnant or lactating women\n26. Legal incapacity or limited legal capacity\n27. Other uncontrolled serious chronic disease or psychiatric condition that in the Investigator's opinion could affect patient safety, compliance, or follow-up in the protocol\n28. Any contraindications to the administration of FOLFOXIRI and bevacizumab at the discretion of the investigator."}, 'identificationModule': {'nctId': 'NCT04607668', 'acronym': 'PRESERVE1', 'briefTitle': 'Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):', 'organization': {'class': 'INDUSTRY', 'fullName': 'G1 Therapeutics, Inc.'}, 'officialTitle': 'PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'G1T28-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trilaciclib + FOLFOXIRI/bevacizumab', 'description': 'During Induction the following study drugs are administered on Day 1:\n\nIrinotecan - IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil - continuous infusion (CI) over 46 to 48 hours beginning on Day 1, Bevacizumab - IV\n\nFollowing completion of Induction, patients will continue in Maintenance, where they will continue to receive trilaciclib per randomization allocation at study entry. Trilaciclib will be administered prior to infusional- 5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.', 'interventionNames': ['Drug: Trilaciclib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + FOLFOXIRI/bevacizumab', 'description': 'The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trilaciclib', 'type': 'DRUG', 'otherNames': ['G1T28', 'CDK 4/6 inhibitor'], 'description': 'Trilaciclib diluted in dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over approximately 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of trilaciclib was administered on Day 2.', 'armGroupLabels': ['trilaciclib + FOLFOXIRI/bevacizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of placebo was administered on Day 2.', 'armGroupLabels': ['placebo + FOLFOXIRI/bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'AZ Oncology Associates - HOPE', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center of USC Pasadena', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope & Innovation\\ Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University - Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists (South Region)', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists NORTH', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid-Florida Hematology & Oncology Centers, P.A.', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital - Georgia Cancer Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comp. 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