Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-28 @ 12:16 PM
Study NCT ID:
NCT04999969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'No unpublished information may be disclosed without prior written approval from AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months.', 'description': 'All adverse events during the trial are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 126, 'seriousNumAtRisk': 126, 'deathsNumAffected': 76, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 99, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 59, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 37, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 60, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 52, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 39, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 126, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 110, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 77, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 48, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 77, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 90, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 75, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 126, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 54, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 51, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 80, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 33, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Duodenal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune-mediated hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemophilus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancreatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly related to treatment', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly related to AZD0171', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}, {'title': 'Any AE possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= CTCAE grade 3, possibly related to treatment', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= CTCAE grade 3, possibly related to AZD0171', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= CTCAE grade 3, possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= CTCAE grade 3, possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Any AE of >= CTCAE grade 3, possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE (Serious Adverse Event)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE possibly related to treatment', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE possibly related to AZD0171', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3, possibly related to treatment', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3, possibly related to AZD0171', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3, possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3, possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE of >= CTCAE grade 3, possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death, possibly related to treatment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death, possibly related to AZD0171', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death, possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death, possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE with outcome death, possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of treatment', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of AZD0171', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Durvalumab', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Gemcitabine', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of treatment, possibly related to treatment', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of AZD0171, possibly related to AZD0171', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Durvalumab, possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to drug interruption of treatment', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to drug interruption of AZD0171', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to drug interruption of Durvalumab', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to drug interruption of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to drug interruption of Gemcitabine', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose reduction of treatment', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose reduction of AZD0171', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose reduction of Durvalumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose reduction of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose reduction of Gemcitabine', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose modification of treatment', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose modification of AZD0171', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose modification of Durvalumab', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose modification of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Any AE leading to dose modification of Gemcitabine', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of treatment', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of AZD0171', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Durvalumab', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Gemcitabine', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of treatment, possibly related to treatment', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of AZD0171, possibly related to AZD0171', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Durvalumab, possibly related to Durvalumab', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to drug interruption of treatment', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to drug interruption of AZD0171', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to drug interruption of Durvalumab', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to drug interruption of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to drug interruption of Gemcitabine', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose reduction of treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose reduction of AZD0171', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose reduction of Durvalumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose reduction of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose reduction of Gemcitabine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose modification of treatment', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose modification of AZD0171', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose modification of Durvalumab', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose modification of Nab-paclitaxel', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to dose modification of Gemcitabine', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE leading to hospitalisation', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Any immune mediated AEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Any infusion reaction AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months', 'description': 'The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set, which included all participants who received any amount of study treatment.\n\nAs specified in the below data table, in the row entitled, 'Any AE leading to dose reduction of AZD0171', one participant had recorded one reduced dose event of AZD0171 by error. This event was not a dose reduction; but, the study treatment was interrupted due to an AE of infusion related reaction, therefore only partial dose was administered."}, {'type': 'PRIMARY', 'title': 'Overall Survival at 12 Months (OS-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '47.79', 'upperLimit': '59.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months.', 'unitOfMeasure': 'Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '29.30', 'upperLimit': '40.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months).', 'description': 'The ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) that occurred prior to the initiation of subsequent anti-cancer treatment and prior to progression. The ORR was assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.', 'unitOfMeasure': 'Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response Evaluable Set (RES), which included all participants who had measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '59.90', 'upperLimit': '71.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 weeks', 'description': 'The DCR is defined as the percentage of participants with a best overall response of confirmed CR or PR, or who had stable disease (SD) maintained for 16 weeks from first dose. DCR was assessed per RECIST v1.1 criteria.', 'unitOfMeasure': 'Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.72', 'groupId': 'OG000', 'lowerLimit': '6.439', 'upperLimit': '9.462'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)', 'description': 'The DoR is defined as the time from first documented objective response (confirmed CR or confirmed PR) until date of first documented disease progression or death (by any cause in the absence of disease progression). The DoR was assessed per RECIST v1.1 criteria.', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Median Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.33', 'groupId': 'OG000', 'lowerLimit': '6.801', 'upperLimit': '7.918'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)', 'description': 'The PFS is defined as the time from first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), whichever was earlier. The PFS was analyzed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival at 4 Months (PFS-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '69.95', 'upperLimit': '80.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 months', 'description': 'The percentage of participants alive and free of progression at 4 months per Kaplan-Meier estimate.', 'unitOfMeasure': 'Percentage', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Median Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.67', 'groupId': 'OG000', 'lowerLimit': '11.565', 'upperLimit': '15.639'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study intervention until death (Up to 35 months) or from first dose of study intervention until last evaluable assessment (Up to 35 months)', 'description': 'The OS is defined as the time from the start of study intervention to the date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set, which included all participants who received any dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 02 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12717.2', 'spread': '95596.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 03 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17463.4', 'spread': '99400.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19283.0', 'spread': '106081.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 05 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19823.2', 'spread': '109490.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 06 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21974.6', 'spread': '115724.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 07 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25249.6', 'spread': '124848.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 08 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26902.4', 'spread': '129722.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 09 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12230.2', 'spread': '31705.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-570.9', 'spread': '29271.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3363.4', 'spread': '6647.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3469.5', 'spread': '6766.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2674.8', 'spread': '6895.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 14 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3100.1', 'spread': '6768.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 15 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1229.7', 'spread': '2027.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1346.8', 'spread': '2040.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 17 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1470.2', 'spread': '2171.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 18 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1867.5', 'spread': '2666.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 19 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1868.8', 'spread': '2691.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 20 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1928.7', 'spread': '3255.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 21 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1830.8', 'spread': '2663.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 22 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1903.7', 'spread': '3244.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 23 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1854.3', 'spread': '3240.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 24 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2764.5', 'spread': '3909.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 25 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': 'NA', 'comment': 'Standard deviation is not calculable due to insufficient number of participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 26 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation is not calculable due to insufficient number of participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 27 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': 'NA', 'comment': 'Standard deviation is not calculable due to insufficient number of participants', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-471.3', 'spread': '145796.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19574.2', 'spread': '114348.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each Cycle through Cycle 27 (each cycle was 28 days in length), at end of treatment and at Day 28 follow up (post last dose); up to 35 months', 'description': 'Mean change from baseline was assessed for serum CA19-9', 'unitOfMeasure': 'Units/milliliter (U/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic (PD) set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'ADA positive at baseline and/or post-baseline (ADA prevalence) (a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Emergent-ADA positive AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-induced ADA positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-boosted ADA positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Both baseline and post-baseline positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Only baseline positive (c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ADA persistently positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ADA transiently positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months', 'description': 'Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity set, which included all participants who received at least one dose of investigational product (IP) with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, \\[a\\] Participants with ADA result at baseline and/or post-baseline \\[b\\] Participants with ADA result at baseline and ≥1 post-baseline \\[c\\] Participants with ADA result at baseline only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'ADA positive at baseline and/or post-baseline (ADA prevalence) (a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Emergent-ADA positive (ADA incidence) (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-induced ADA positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-boosted ADA positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Both baseline and post-baseline positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Only baseline positive (c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ADA persistently positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ADA transiently positive (b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months', 'description': 'Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity set, which included all participants who received at least one dose of IP with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, \\[a\\] Number of participants with ADA result at baseline and/or post-baseline \\[b\\] Number of participants with ADA result at baseline and ≥1 post-baseline \\[c\\] Number of participants with ADA result at baseline only.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '395.4', 'spread': '16.84', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '694.6', 'spread': '31.62', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The maximum concentration of AZD0171 was determined.', 'unitOfMeasure': 'microgram/mililiter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the noncompartmental analysis (NCA). Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1996', 'spread': '176.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1113', 'spread': '553.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The Cmax of Nab-paclitaxel was determined.', 'unitOfMeasure': 'nanogram/mililiter (ng/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '56570', 'spread': '77.33', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days in length)', 'description': 'The AUCinf of AZD0171 was determined.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'AUClast Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38600', 'spread': '87.50', 'groupId': 'OG000'}]}]}, {'title': 'AUClast Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66290', 'spread': '44.47', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The AUClast of AZD0171 was determined.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'AUClast Cycle 01 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3992', 'spread': '63.70', 'groupId': 'OG000'}]}]}, {'title': 'AUClast Cycle 04 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2853', 'spread': '107.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The AUClast of Nab-paclitaxel was determined.', 'unitOfMeasure': 'hour*nanogram/milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'AUCtau Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43770', 'spread': '55.76', 'groupId': 'OG000'}]}]}, {'title': 'AUCtau Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81760', 'spread': '14.11', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The AUCtau of AZD0171 was determined.', 'unitOfMeasure': 'hour*microgram/milliliter (h*ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'AUCtau Cycle 01 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4550', 'spread': '54.03', 'groupId': 'OG000'}]}]}, {'title': 'AUCtau Cycle 04 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3302', 'spread': '98.07', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The AUCtau of Nab-paclitaxel was determined.', 'unitOfMeasure': 'hour*nanogram/milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02651', 'spread': '77.33', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01835', 'spread': '14.11', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 and Day 1 (each cycle is 28 days in length)', 'description': 'The CL of AZD0171 was determined.', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Nab-paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.37', 'spread': '67.48', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.13', 'spread': '99.70', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The CL of Nab-paclitaxel was determined.', 'unitOfMeasure': 'Liter/hour/meter square (L/h/m**2)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t1/2λz) of AZD0171', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127.4', 'spread': '77.48', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '188.2', 'spread': '6.567', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The t1/2λz of AZD0171 was determined.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.353', 'spread': '85.14', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.509', 'spread': '20.20', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The t1/2λz of Nab-paclitaxel was determined.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}, {'type': 'SECONDARY', 'title': 'Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Central tumor region', 'categories': [{'measurements': [{'value': '2.86', 'spread': '378.12', 'groupId': 'OG000'}]}]}, {'title': 'Central tumor region - within Pan-cytokeratin (PanCK)- Tumor Stroma Area', 'categories': [{'measurements': [{'value': '-10.66', 'spread': '460.92', 'groupId': 'OG000'}]}]}, {'title': 'Central tumor region- within PanCK+ Carcinoma Cell Compartment', 'categories': [{'measurements': [{'value': '-25.68', 'spread': '329.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In cycle 3 (each cycle was 28 days in length), subsequent to the first disease assessment scan conducted at roughly 8 weeks.', 'description': 'The changes in CD8+ T cell tumour infiltration (on-treatment during cycle 3 minus baseline) associated with AZD0171 treatment in combination with durvalumab and chemotherapy was assessed in participants with 1L metastatic pancreatic ductal adenocarcinoma.', 'unitOfMeasure': 'Cells/millimeter square', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'classes': [{'title': 'Cycle 01 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.01', 'spread': '55.91', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 01 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '284.6', 'spread': '93.92', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 02 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '195.5', 'spread': '85.89', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 02 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '174.9', 'spread': '69.12', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 03 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201.4', 'spread': '106.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 03 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.2', 'spread': '63.66', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.2', 'spread': '59.66', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 04 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.5', 'spread': '71.98', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 05 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.2', 'spread': '71.97', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 06 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '182.5', 'spread': '96.65', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 07 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '310.0', 'spread': 'NA', 'comment': 'Standard deviation is not calculable due to insufficient number of participants', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 08 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '187.8', 'spread': '94.74', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11 Day 01', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '133.2', 'spread': '50.24', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 1 and Day 15, Cycle 5Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 (each cycle is 28 days in length)', 'description': 'Serum concentration of LIF bound to AZD0171 (total LIF) was assessed.', 'unitOfMeasure': 'picogram/millilitre (pg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The study enrolled participants across 39 sites in 4 countries. The enrollment period began on December 10, 2021, and the analyses presented in this form are based on clinical data lock date of November 16, 2024.', 'preAssignmentDetails': 'Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All the study assessments were performed as per the schedule of assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD0171 + Durvalumab + Chemotherapy', 'description': 'Participants received AZD0171 (intravenous \\[IV\\]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) set, which included all participants who received any dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-03', 'size': 3844337, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-06T07:23', 'hasProtocol': True}, {'date': '2024-09-26', 'size': 2681926, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-06T07:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-08-03', 'resultsFirstSubmitDate': '2025-10-06', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months', 'description': 'The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.'}, {'measure': 'Overall Survival at 12 Months (OS-12)', 'timeFrame': 'At 12 months', 'description': 'Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months).', 'description': 'The ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) that occurred prior to the initiation of subsequent anti-cancer treatment and prior to progression. The ORR was assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 16 weeks', 'description': 'The DCR is defined as the percentage of participants with a best overall response of confirmed CR or PR, or who had stable disease (SD) maintained for 16 weeks from first dose. DCR was assessed per RECIST v1.1 criteria.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)', 'description': 'The DoR is defined as the time from first documented objective response (confirmed CR or confirmed PR) until date of first documented disease progression or death (by any cause in the absence of disease progression). The DoR was assessed per RECIST v1.1 criteria.'}, {'measure': 'Median Progression Free Survival (PFS)', 'timeFrame': 'From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)', 'description': 'The PFS is defined as the time from first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), whichever was earlier. The PFS was analyzed using the Kaplan-Meier method.'}, {'measure': 'Progression Free Survival at 4 Months (PFS-4)', 'timeFrame': 'At 4 months', 'description': 'The percentage of participants alive and free of progression at 4 months per Kaplan-Meier estimate.'}, {'measure': 'Median Overall Survival (OS)', 'timeFrame': 'From first dose of study intervention until death (Up to 35 months) or from first dose of study intervention until last evaluable assessment (Up to 35 months)', 'description': 'The OS is defined as the time from the start of study intervention to the date of death due to any cause.'}, {'measure': 'Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)', 'timeFrame': 'Day 1 of each Cycle through Cycle 27 (each cycle was 28 days in length), at end of treatment and at Day 28 follow up (post last dose); up to 35 months', 'description': 'Mean change from baseline was assessed for serum CA19-9'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum', 'timeFrame': 'Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months', 'description': 'Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum', 'timeFrame': 'Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months', 'description': 'Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The maximum concentration of AZD0171 was determined.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The Cmax of Nab-paclitaxel was determined.'}, {'measure': 'Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 (each cycle is 28 days in length)', 'description': 'The AUCinf of AZD0171 was determined.'}, {'measure': 'Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The AUClast of AZD0171 was determined.'}, {'measure': 'Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The AUClast of Nab-paclitaxel was determined.'}, {'measure': 'Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The AUCtau of AZD0171 was determined.'}, {'measure': 'Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The AUCtau of Nab-paclitaxel was determined.'}, {'measure': 'Clearance (CL) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 and Day 1 (each cycle is 28 days in length)', 'description': 'The CL of AZD0171 was determined.'}, {'measure': 'Clearance (CL) of Nab-paclitaxel', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The CL of Nab-paclitaxel was determined.'}, {'measure': 'Terminal Elimination Half-life (t1/2λz) of AZD0171', 'timeFrame': 'Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length)', 'description': 'The t1/2λz of AZD0171 was determined.'}, {'measure': 'Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel', 'timeFrame': 'Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length)', 'description': 'The t1/2λz of Nab-paclitaxel was determined.'}, {'measure': 'Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region', 'timeFrame': 'In cycle 3 (each cycle was 28 days in length), subsequent to the first disease assessment scan conducted at roughly 8 weeks.', 'description': 'The changes in CD8+ T cell tumour infiltration (on-treatment during cycle 3 minus baseline) associated with AZD0171 treatment in combination with durvalumab and chemotherapy was assessed in participants with 1L metastatic pancreatic ductal adenocarcinoma.'}, {'measure': 'Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time', 'timeFrame': 'Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 1 and Day 15, Cycle 5Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 (each cycle is 28 days in length)', 'description': 'Serum concentration of LIF bound to AZD0171 (total LIF) was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AZD0171', 'Durvalumab', 'Gemcitabine', 'Nab-paclitaxel', 'Leukaemia inhibitory factor', 'Pancreatic ductal adenocarcinoma', 'Immunotherapy'], 'conditions': ['Locally Advanced or Metastatic Solid Tumours']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8151C00001&attachmentIdentifier=e7b04e49-2ac7-41d1-9909-8772adced022&fileName=258542_Redacted_CSP_Final_PDF.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8151C00001&attachmentIdentifier=dfaea5fa-b524-4325-8b02-e6f497820249&fileName=258542_Redacted_CSR_Synopsis_Final_PDF.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8151C00001&attachmentIdentifier=4f2e8e34-5b4c-4710-be00-39f3a52ff50d&fileName=258542_Redacted_SAP_Final_PDF.pdf&versionIdentifier=', 'label': 'Redacted SAP'}]}, 'descriptionModule': {'briefSummary': 'The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).', 'detailedDescription': 'This is a Phase II, open-label, single arm, multicentre study to assess the safety, preliminary antitumour activity, immunogenicity, pharmacodynamics (PD), and pharmacokinetics (PK) of AZD0171 in combination with durvalumab and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in participants with first line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC).\n\nAll participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment\n* Must have a Gustave Roussy Immune Score of 0 or 1\n* Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma\n* Participants must have at least 1 measurable lesion to be called a target lesion according to RECIST v1.1\n* All participants must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment\n* Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample\n* Normal organ and bone marrow function measured within 28 days prior to first dose of study intervention\n* Body weight ≥ 35 kg\n\nExclusion Criteria:\n\n* Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression\n* A participant with an already known sensitising mutation or tumour characteristic for pancreatic cancer for which there is a preferred local standard-of-care treatment\n* History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention\n* Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes)\n* History of solid organ transplantation\n* History of active primary immunodeficiency\n* Ongoing or an active infection, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. A negative COVID-19 PCR test taken within 28 days of the start of the study treatment is required.\n* Uncontrolled intercurrent illness\n* Participants with prior history of myocardial infarction, transient ischemic attack, coronary bypass, or stroke within the past 3 months prior to the first dose of study intervention\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms\n* Active or prior documented autoimmune or inflammatory disorders\n* History of another primary malignancy\n* Receipt of any conventional or investigational anticancer therapy prior to the scheduled first dose of study intervention\n* Prior receipt of any immune-mediated therapy\n* Use of immunosuppressive medication within 14 days prior to the first dose of study intervention\n* Receipt of live, attenuated vaccine within 28 days prior to the first dose of study intervention (Participants can receive non-live COVID-19 vaccines, at the discretion of the Investigator)"}, 'identificationModule': {'nctId': 'NCT04999969', 'briefTitle': 'Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours', 'orgStudyIdInfo': {'id': 'D8151C00001'}, 'secondaryIdInfos': [{'id': '2021-002040-78', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD0171 + Durvalumab + chemotherapy', 'description': 'Participants will receive AZD0171 (intravenous \\[IV\\]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).', 'interventionNames': ['Drug: AZD0171', 'Drug: Durvalumab', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'AZD0171', 'type': 'DRUG', 'otherNames': ['MSC-1'], 'description': 'AZD0171', 'armGroupLabels': ['AZD0171 + Durvalumab + chemotherapy']}, {'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab', 'armGroupLabels': ['AZD0171 + Durvalumab + chemotherapy']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Chemotherapy (Standard-of-Care)', 'armGroupLabels': ['AZD0171 + Durvalumab + chemotherapy']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Chemotherapy (Standard-of-Care)', 'armGroupLabels': ['AZD0171 + Durvalumab + chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 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