Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT03830866
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2018-12-04
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)', 'description': 'There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384', 'eventGroups': [{'id': 'EG000', 'title': 'Durva + SoC CCRT', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 385, 'deathsNumAtRisk': 385, 'otherNumAffected': 373, 'seriousNumAtRisk': 385, 'deathsNumAffected': 91, 'seriousNumAffected': 113}, {'id': 'EG001', 'title': 'Placebo + SoC CCRT', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 384, 'deathsNumAtRisk': 385, 'otherNumAffected': 368, 'seriousNumAtRisk': 384, 'deathsNumAffected': 112, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 56, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 48, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 47, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 216, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 221, 'numAffected': 85}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 81, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 107, 'numAffected': 62}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 46, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 46, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 53, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 296, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 340, 'numAffected': 85}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 103, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 74, 'numAffected': 64}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 34, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 63, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 74, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 61, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 51, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 49, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 55, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 51, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 34, 'numAffected': 33}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 74, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 80, 'numAffected': 70}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 48, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 41, 'numAffected': 37}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 37, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 68, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 315, 'numAffected': 209}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 322, 'numAffected': 200}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 71, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 68, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 119, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 106, 'numAffected': 87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 257, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 289, 'numAffected': 190}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 289, 'numAffected': 213}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 293, 'numAffected': 202}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 194, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 202, 'numAffected': 107}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 43, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 55, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 79, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 51, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 37, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 100, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 120, 'numAffected': 58}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 46, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 59, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 51, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 123, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 124, 'numAffected': 92}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 120, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 100, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Radiation proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 64, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 48, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Electrocardiogram q wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Full blood count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numEvents': 0, 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For patients who did not progress their DoR was their Progression-free survival censoring time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Durvalumab', 'Chemoradiotherapy', 'Locally Advanced Cervical Cancer'], 'conditions': ['Locally Advanced Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '38039991', 'type': 'DERIVED', 'citation': 'Monk BJ, Toita T, Wu X, Vazquez Limon JC, Tarnawski R, Mandai M, Shapira-Frommer R, Mahantshetty U, Del Pilar Estevez-Diz M, Zhou Q, Limaye S, Godinez FJR, Oppermann Kussler C, Varga S, Valdiviezo N, Aoki D, Leiva M, Lee JY, Sulay R, Kreynina Y, Cheng WF, Rey F, Rong Y, Ke G, Wildsmith S, Lloyd A, Dry H, Tablante Nunes A, Mayadev J. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1334-1348. doi: 10.1016/S1470-2045(23)00479-5.'}, {'pmid': '32447296', 'type': 'DERIVED', 'citation': 'Mayadev J, Nunes AT, Li M, Marcovitz M, Lanasa MC, Monk BJ. CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study. Int J Gynecol Cancer. 2020 Jul;30(7):1065-1070. doi: 10.1136/ijgc-2019-001135. 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