Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT04716634
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C000591844', 'term': 'HMPL-013'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '+1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality data was collected through the end of study, that is, up to 2 years 9 months. Adverse event data was collected from the date of the first dose of study drug up to 30 days after the last dose of study drug (up to approximately 2 years and 5 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 28, 'seriousNumAtRisk': 31, 'deathsNumAffected': 24, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 29, 'seriousNumAtRisk': 31, 'deathsNumAffected': 24, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'deathsNumAffected': 8, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hypopituitarism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Angular cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Duodenogastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Periodontal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gallbladder obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Immune-mediated hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Multisystem inflammatory syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Diabetic ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Gingival cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 26.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab and Fruquintinib', 'description': 'All participants received the full dose of fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 Days', 'description': 'A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the DLT evaluable analysis set that included all participants in Part 1 who received at least 85% of the assigned total dose of fruquintinib and at least 67% of the assigned total dose of tislelizumab during the DLT assessment period.'}, {'type': 'PRIMARY', 'title': 'Part 1: Recommended Phase 2 Dose (RP2D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab and Fruquintinib', 'description': 'All participants received the full dose of fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 Days', 'description': 'RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.', 'unitOfMeasure': 'milligrams (mg) per day', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the DLT evaluable analysis set.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '29.8'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '25.8'}, {'value': '40.9', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '63.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set which included all participants who received at least 1 dose of study drug(s).'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '7.4'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '7.2'}, {'value': '15.6', 'comment': 'The upper limit of 95% confidence interval (CI) could not be calculated due to fewer number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first dose of study drug until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (PD) or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '88.1'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '88.1'}, {'value': '68.2', 'groupId': 'OG002', 'lowerLimit': '45.1', 'upperLimit': '86.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'DCR was defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by investigator as per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '51.4'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '57.8'}, {'value': '59.1', 'groupId': 'OG002', 'lowerLimit': '36.4', 'upperLimit': '79.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'CBR was defined as the percentage of participants whose best overall response is CR, PR, or durable stable disease (SD) as assessed by the investigator per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': 'NA'}, {'value': '11.9', 'comment': 'The upper limit of 95% CI could not be calculated due to fewer number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first objective response to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years and 9 months)', 'description': 'DOR was defined as the time from the first occurrence of documented objective response to the time of progression as assessed by investigator per RECIST v1.1 or death from any cause, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using participants in the safety analysis set with an objective response.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '14.6'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '15.2'}, {'value': 'NA', 'comment': 'Median and the upper limit of 95% CI could not be calculated due to fewer number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of the study treatment to date of death from any cause (up to 2 years and 9 months)', 'description': 'OS was defined as the time from the date of first dose to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'OG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 or Higher TEAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs Leading to Death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs Related to Tislelizumab', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs Related to Fruquintinib', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of the first dose of study drug up to 30 days after the last dose of study drug; up to approximately 2 years and 5 months.', 'description': 'A TEAE was defined as an AE that had an onset date or a worsening in severity from baseline (pre-treatment) on or after the first dose of study drug(s) and up to 30 days following study drug(s) discontinuation or initiation of new anticancer therapy, whichever occurred first determined according to NCI-CTCAE v5.0. Treatment emergent serious Adverse Events (TESAEs): any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator. AEs were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (mg) daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'FG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'FG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (NSCLC) received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Closed by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study consisted of 2 parts: Part 1 (Safety run-in) and Part 2 (Extension). Part 1 of the study with limited participants assessed dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D). These participants later moved to Part 2 of the study. Participant flow, baseline demographics and adverse event data were planned to be reported and analyzed for the combined Part 1 and Part 2 of study. All participants received same dose of study drugs (tislelizumab and fruquintinib).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'BG001', 'title': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'BG002', 'title': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with PD-L1 expression, and advanced or metastatic, unresectable NSCLC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '7.88', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '11.28', 'groupId': 'BG002'}, {'value': '60.1', 'spread': '9.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on safety analysis set that included all participants who received at least 1 dose of study drug(s).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-16', 'size': 2074158, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-19T16:10', 'hasProtocol': True}, {'date': '2024-02-27', 'size': 738480, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-19T16:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2021-01-13', 'resultsFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-21', 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 28 Days', 'description': 'A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).'}, {'measure': 'Part 1: Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Up to 28 Days', 'description': 'RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.'}, {'measure': 'Objective Response Rate (ORR) as Assessed by the Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) as Assessed by Investigator Based on RECIST v1.1', 'timeFrame': 'From date of first dose of study drug until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (PD) or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.'}, {'measure': 'Disease Control Rate (DCR) as Assessed by the Investigator Based on RECIST v1.1', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'DCR was defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by investigator as per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Clinical Benefit Rate (CBR) as Assessed by the Investigator Based on RECIST v1.1', 'timeFrame': 'From date of randomization until the date of first documented progression or death from any cause, whichever came first (up to 2 years and 9 months)', 'description': 'CBR was defined as the percentage of participants whose best overall response is CR, PR, or durable stable disease (SD) as assessed by the investigator per RECIST v1.1. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Duration of Response (DOR) as Assessed by The Investigator Based on RECIST v1.1', 'timeFrame': 'From the first objective response to the date of first documentation of disease progression or death, whichever occurs first (up to 2 years and 9 months)', 'description': 'DOR was defined as the time from the first occurrence of documented objective response to the time of progression as assessed by investigator per RECIST v1.1 or death from any cause, whichever occurs first. Median DOR was estimated using the Kaplan-Meier method.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first dose of the study treatment to date of death from any cause (up to 2 years and 9 months)', 'description': 'OS was defined as the time from the date of first dose to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Grade 3 or Higher TEAEs, TEAEs Leading to Death, TEAEs Related to Tislelizumab, TEAEs Related to Fruquintinib', 'timeFrame': 'From the date of the first dose of study drug up to 30 days after the last dose of study drug; up to approximately 2 years and 5 months.', 'description': 'A TEAE was defined as an AE that had an onset date or a worsening in severity from baseline (pre-treatment) on or after the first dose of study drug(s) and up to 30 days following study drug(s) discontinuation or initiation of new anticancer therapy, whichever occurred first determined according to NCI-CTCAE v5.0. Treatment emergent serious Adverse Events (TESAEs): any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator. AEs were graded for severity using NCI-CTCAE v5.0, where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; and Grade 5: Death related to AE. The TEAEs leading to death in this data table exclude death due to disease under study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid tumors'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC), or colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). The study was conducted in 2 parts. Part 1 was the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 assessed the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.', 'detailedDescription': 'This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic, unresectable GC, and CRC or NSCLC. The study was conducted in 2 parts.\n\nPart 1 of the study was the safety run-in stage which assessed dose-limiting toxicities (DLTs) and RP2D. Part 2 began at RP2D. Participants enrolled in Part 1 at RP2D were counted towards Part 2; up to approximately 30 patients per cohort were enrolled at RP2D.\n\nThe primary outcome measure of the study was ORR as assessed by the investigator as per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Tislelizumab and fruquintinib were administered until disease progression, intolerable toxicity, death, withdrawal of consent or until the study terminates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Signed informed consent form (ICF) and able to comply with study requirements.\n2. At least 1 measurable lesion as defined by RECIST v1.1\n3. Tumor tissue (archival tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\\<=) 1\n5. Histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction or colon or rectum, and histologically or cytologically confirmed, locally advanced (Stage IIIB) not amenable to curative surgery or radiotherapy, or metastatic (Stage IV) NSCLC\n\nKey Exclusion Criteria:\n\n1. Had at screening any central nervous system metastasis and/or leptomeningeal disease\n2. Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways\n3. Prior treatment with VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab)\n4. Received more than 1 line of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction, or more than 2 lines of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of the colon or rectum, or prior systemic therapy for advanced or metastatic NSCLC\n5. Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04716634', 'briefTitle': 'Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Multicenter, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors', 'orgStudyIdInfo': {'id': 'BGB-A317-fruquintinib-201'}, 'secondaryIdInfos': [{'id': 'CTR20211070', 'type': 'OTHER', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (mg) daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Fruquintinib']}, {'type': 'EXPERIMENTAL', 'label': 'Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'description': 'Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Fruquintinib']}, {'type': 'EXPERIMENTAL', 'label': 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib', 'description': 'Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (NSCLC) received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Fruquintinib']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317'], 'description': 'Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.', 'armGroupLabels': ['Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib']}, {'name': 'Fruquintinib', 'type': 'DRUG', 'otherNames': ['HMPL-013'], 'description': 'Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)', 'armGroupLabels': ['Colorectal Cancer (CRC): Tislelizumab and Fruquintinib', 'Gastric Cancer (GC): Tislelizumab and Fruquintinib', 'PD-L1 + NSCLC: Tislelizumab and Fruquintinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '252000', 'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': 'Liaocheng Peoples Hospital', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '276001', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jian Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'url': 'http://beigene.com/science/clinical-trials/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': 'BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.\n\nBeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.\n\nQualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.', 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hutchison Medipharma Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}