Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-01 @ 3:51 PM
Study NCT ID:
NCT02643420
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2015-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583329', 'term': 'eflapegrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shanta.chawla@sppirx.com', 'phone': '(949) 788-6700', 'title': 'Shanta Chawla', 'organization': 'Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)', 'description': 'The safety population included all participants who had received at least one dose of any protocol specified drug (TC, SPI-2012, or pegfilgrastim). One participant was randomized to pegfilgrastim received SPI-2012 and was included in the Safety Population. Adverse events data was summarized and reported separately for the Treatment Period and Follow-up Period.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: SPI-2012 and TC -Treatment Period', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.", 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 192, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Arm 2: Pegfilgrastim and TC -Treatment Period', 'description': "Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.", 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 203, 'seriousNumAtRisk': 208, 'deathsNumAffected': 1, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Arm 1: SPI-2012 and TC - Follow up Period', 'description': 'In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 92, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Arm 2: Pegfilgrastim and TC - Follow up Period', 'description': 'In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 82, 'seriousNumAtRisk': 208, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 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{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, 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'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-cardiogenic pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, 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'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 208, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Severe Neutropenia (DSN) in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.503', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.683', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.148', 'ciLowerLimit': '-0.266', 'ciUpperLimit': '-0.031', 'statisticalMethod': 't-statistics', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.', 'nonInferiorityComment': 'The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \\<0.62 days.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)', 'description': 'DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \\[ANC\\] \\<0.5×10\\^9/L), after the administration of study drug in Cycle 1.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'spread': '3.565', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '3.589', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10\\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\\^9/L.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'spread': '3.086', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '3.317', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.56', 'statisticalMethod': 'Asymptotic normality assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) in Cycle 1.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Febrile Neutropenia (FN) in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.435', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '10.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'FN was defined as an oral temperature \\> 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit \\[F\\]) or two consecutive readings of \\>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \\<1.0×10\\^9/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Severe Neutropenia in Cycle 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.383', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.374', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.326', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.273', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.281', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.116', 'groupDescription': 'DSN in Cycle 2', 'statisticalMethod': 't-statistics', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \\<0.62 days.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.026', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.085', 'groupDescription': 'DSN in Cycle 3', 'statisticalMethod': 't-statistics', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \\<0.62 days.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.027', 'ciLowerLimit': '-0.036', 'ciUpperLimit': '0.089', 'groupDescription': 'DSN in Cycle 4', 'statisticalMethod': 't-statistics', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \\<0.62 days.'}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)', 'description': 'DSN was defined as the number of days of severe neutropenia (ANC \\<0.5×10\\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutropenic Complications in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '10.0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who was randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '9.8', 'groupDescription': 'FN in Cycle 2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '11.3', 'groupDescription': 'FN in Cycle 3', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '10.8', 'groupDescription': 'FN in Cycle 4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle was 21 days)', 'description': 'FN was defined as an oral temperature \\> 38.3 degrees C (101.0 degrees Fahrenheit \\[F\\]) or two consecutive readings of \\>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \\<1.0×10\\^9/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'classes': [{'title': 'Docetaxel', 'categories': [{'measurements': [{'value': '99.1', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '98.1', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': 'Cyclophosphamide', 'categories': [{'measurements': [{'value': '99.3', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '99.0', 'spread': '4.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 to 4 (each cycle was 21 days)', 'description': 'RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.', 'unitOfMeasure': 'percentage of planned dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 and TC -Treatment Period', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation."}, {'id': 'OG001', 'title': 'Arm 2: Pegfilgrastim and TC -Treatment Period', 'description': "Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation."}, {'id': 'OG002', 'title': 'Arm 1: SPI-2012 and TC - Follow up Period', 'description': 'In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.'}, {'id': 'OG003', 'title': 'Arm 2: Pegfilgrastim and TC - Follow up Period', 'description': 'In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of any protocol-specified drug (TC, SPI-2012 or pegfilgrastim). One participant was randomized to pegfilgrastim but was given SPI-2012 in Safety Population. Data was summarized and reported separately for Treatment Period and Follow-up Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)', 'description': "Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \\[G-CSF\\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'FG001', 'title': 'Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'Safety Population', 'comment': 'Safety Population included all participants who had received at least one dose of any protocol specified drug (TC, SPI-2012, or pegfilgrastim).', 'achievements': [{'comment': 'One participant was randomized to the Arm 2: Pegfilgrastim and TC but was inadvertently administered SPI-2012 on Cycle 1, Day 2 and was included in the Arm 1: SPI-2012 and TC for the Safety Population.', 'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Initiation of Non-Protocol Therapy for Breast Cancer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Treatment with Additional Myeloid Growth Factors During Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 19 Jan 2016 to 31 Oct 2018. A total of 406 participants were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: SPI-2012 and TC', 'description': "Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'BG001', 'title': 'Arm 2: Pegfilgrastim and TC', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '11.79', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '11.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to Treat (ITT) population included all participants who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-26', 'size': 3703979, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-23T08:37', 'hasProtocol': True}, {'date': '2018-07-31', 'size': 1098373, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-23T08:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2020-01-23', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2015-12-29', 'dispFirstSubmitQcDate': '2020-01-23', 'resultsFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2015-12-29', 'dispFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Severe Neutropenia (DSN) in Cycle 1', 'timeFrame': 'Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)', 'description': 'DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \\[ANC\\] \\<0.5×10\\^9/L), after the administration of study drug in Cycle 1.'}], 'secondaryOutcomes': [{'measure': 'Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Time to ANC Recovery was defined as the time from chemotherapy administration until ANC increased to ≥1.5×10\\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was assigned as 0 for participants whose ANC value never dropped below 1.5 x10\\^9/L.'}, {'measure': 'Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or Pegfilgrastim) in Cycle 1.'}, {'measure': 'Number of Participants With Febrile Neutropenia (FN) in Cycle 1', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'FN was defined as an oral temperature \\> 38.3 degrees Celsius (C) (101.0 degrees Fahrenheit \\[F\\]) or two consecutive readings of \\>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \\<1.0×10\\^9/L.'}, {'measure': 'Duration of Severe Neutropenia in Cycle 2, 3 and 4', 'timeFrame': 'Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)', 'description': 'DSN was defined as the number of days of severe neutropenia (ANC \\<0.5×10\\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.'}, {'measure': 'Number of Participants With Neutropenic Complications in Cycle 1', 'timeFrame': 'Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)', 'description': 'Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.'}, {'measure': 'Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4', 'timeFrame': 'Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle was 21 days)', 'description': 'FN was defined as an oral temperature \\> 38.3 degrees C (101.0 degrees Fahrenheit \\[F\\]) or two consecutive readings of \\>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \\<1.0×10\\^9/L.'}, {'measure': 'Relative Dose Intensity (RDI) of TC (Docetaxel + Cyclophosphamide) in Cycles 1 to 4', 'timeFrame': 'Cycles 1 to 4 (each cycle was 21 days)', 'description': 'RDI was defined as the percentage of the planned dose that each participant actually received during the study, expressed as the total dose received, divided by the total dose planned and multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE for Treatment Period is defined as adverse event with an onset date on or after the date of study drug administration through the end of treatment. TEAE for follow up is defined as any new onset or ongoing AE at the end of Treatment. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neutropenia', 'Breast Cancer', 'Long-acting Myeloid Growth Factor', 'Early Stage Breast Cancer', 'Docetaxel + Cyclophosphamide (TC) chemotherapy'], 'conditions': ['Neutropenia', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.', 'detailedDescription': 'This was a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 vs pegfilgrastim in participants with breast cancer treated with TC chemotherapy.\n\nEach cycle was 21 days. Four cycles were evaluated in this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer\n* Candidate for adjuvant or neoadjuvant TC chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1.5×10\\^9/L\n* Platelet count ≥ 100×10\\^9/L\n* Hemoglobin \\> 9 g/dL\n* Creatinine clearance \\> 50 mL/min\n* Total bilirubin ≤ 1.5 mg/dL\n* Aspartate Aminotransferase per Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) and Alanine Aminotransferase per Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) ≤ 2.5× Upper Limit of Normal (ULN).\n* Alkaline phosphatase ≤ 2.0×ULN\n\nKey Exclusion Criteria:\n\n* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease\n* Locally recurrent or metastatic breast cancer\n* Known sensitivity to E. coli -derived products or to any products to be administered during dosing\n* Concurrent adjuvant cancer therapy\n* Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug\n* Active infection, receiving anti-infectives, or any serious underlying medical condition that would impair ability to receive protocol treatment\n* Prior bone marrow or stem cell transplant\n* Use of any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study\n* Radiation therapy within 30 days prior to enrollment\n* Major surgery within 30 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT02643420', 'acronym': 'ADVANCE', 'briefTitle': 'SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)', 'orgStudyIdInfo': {'id': 'SPI-GCF-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)', 'description': "Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \\[G-CSF\\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.", 'interventionNames': ['Drug: SPI-2012', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)', 'description': "Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.", 'interventionNames': ['Drug: Pegfilgrastim', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'SPI-2012', 'type': 'DRUG', 'otherNames': ['Rolontis®', 'Eflapegrastim', '(HM10460A)'], 'description': 'Single-use syringes for subcutaneous injection, administered on Day 2 of each cycle', 'armGroupLabels': ['Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'otherNames': ['Neulasta®'], 'description': 'Single-dose subcutaneous injection administered on Day 2 of each cycle', 'armGroupLabels': ['Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Standard therapy', 'armGroupLabels': ['Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)', 'Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Standard therapy', 'armGroupLabels': ['Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)', 'Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Center for Cancer Care', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center/ ACRC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Yuma Regional Medical Center', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center', 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