Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 6:23 AM
Study NCT ID:
NCT01724866
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}], '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'}]}, '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 up to 30 days post last dose of study drug (up to 4 months)', 'description': 'The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 36, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 33, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 33, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Severe Neutropenia (DSN) in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '1.547', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '1.275', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.167', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '0.822', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.19', 'ciUpperLimit': '1.27', 'groupDescription': 'A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.64', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.06', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 1.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Duration of DSN in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '1.022', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.478', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.171', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.368', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.74', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.24', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.06', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 2.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of DSN in Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '1.132', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.628', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.610', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.593', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.72', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.30', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.28', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 3.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of DSN in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '4.579', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.738', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.522', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.404', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '2.47', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.38', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.22', 'groupDescription': 'A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the upper CI was \\< 1 day.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 4.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Recovery in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '11.0'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '9.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '9.0'}, {'value': '9.0', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.8', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.711', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.4', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.028', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.9', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10\\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 1.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Recovery in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '11.0'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '10.0'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '14.0'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '11.0'}]}]}], 'analyses': [{'pValue': '0.672', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.4', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.348', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.3', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.973', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.4', 'ciUpperLimit': '2.9', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 2.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 2.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Recovery in Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '11.0'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '12.0'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '13.0'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '11.0'}]}]}], 'analyses': [{'pValue': '0.618', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.4', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.661', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.6', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.754', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.8', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 3.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 3.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Recovery in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '13.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '11.0'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '14.0'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '11.0'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.7', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.527', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.8', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.815', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.4', 'ciUpperLimit': '3.9', 'groupDescription': 'A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 4.", 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 4.'}, {'type': 'SECONDARY', 'title': 'Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.86', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '5.47', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '2.43', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.911', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.', 'unitOfMeasure': '10^9 ANC per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Absolute ANC Nadir Overtime in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '6.30', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '2.16', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.633', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.027', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute ANC Nadir Overtime in Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '4.81', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '1.92', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.571', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.066', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute ANC Nadir Overtime in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.86', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '1.64', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.156', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}, {'pValue': '0.005', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Asymptotic Normality Assumption', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.'}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Depth of ANC Nadir in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '14.1'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '21.0'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.80', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.53', 'ciUpperLimit': '2.04', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.40', 'ciUpperLimit': '4.54', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Depth of ANC Nadir in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '8.0'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '9.5'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '25.7'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '9.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.80', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.79', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.07', 'ciUpperLimit': '2.79', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Depth of ANC Nadir in Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.3'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '21.4'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '8.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.89', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.85', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.97', 'ciUpperLimit': '2.49', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Depth of ANC Nadir in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '11.2'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '11.9'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '6.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.10', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.38', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.23', 'ciUpperLimit': '2.96', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.', 'unitOfMeasure': '10^9 ANC/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Nadir in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '7.0', 'comment': 'The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': 'NA'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '16.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Nadir in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'comment': 'The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': 'NA'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Nadir in Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'comment': 'The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': 'NA'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '9.0'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Nadir in Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'comment': 'The upper limit of Kaplan-Meier 95% confidence interval was not estimable due to too many events at median value.', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': 'NA'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '21.0'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}, {'value': '5.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '24.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-26.7', 'ciUpperLimit': '21.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-26.7', 'ciUpperLimit': '21.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 to Cycle 4 (each cycle was 21 days)', 'description': 'FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10\\^9/L..', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'title': 'Grade 3-4 TEAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SAEs Other Than Death', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Discontinuation From Study Therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3-4 Lab Abnormalities: Hematology', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3-4 Lab Abnormalities: Chemistry', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose up to 30 days post last dose of study drug (up to 4 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities ("Hematology and Chemistry") were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}, {'value': '13.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.469', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-28.5', 'ciUpperLimit': '16.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.710', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-29.3', 'ciUpperLimit': '18.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.199', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.1', 'ciLowerLimit': '-34.6', 'ciUpperLimit': '13.3', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Antibodies for SPI-2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to the end of the study (Approximately 3.5 months)', 'description': 'Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed included participants who were treated with SPI-2012 and had post-treatment samples collected, and excluded participants who tested positive before being treated with SPI-2012. Data was collected and analyzed only for the "SPI-2012" reporting arms as per the planned analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Concentration of SPI-2012 (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '70.5'}, {'value': '9.00', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '48.1'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '24.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.', 'unitOfMeasure': 'hours (hrs)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and have sufficient number of blood samples. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of SPI-2012 (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '247', 'spread': '276', 'groupId': 'OG001'}, {'value': '299', 'spread': '329', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and had sufficient number of blood samples. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '16000', 'spread': '5850', 'groupId': 'OG001'}, {'value': '22900', 'spread': '25100', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and have sufficient number of blood samples to estimate AUC. The AUC0-312 was not calculated for the 45 µg/kg dose due to insufficient data in the serum concentration profiles. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Half-life of SPI-2012 (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'OG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'spread': '88.4', 'groupId': 'OG001'}, {'value': '31.5', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 't1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included subset of participants who had received at least one dose of SPI-2012 in Arms 1 to 3 and had sufficient number of blood samples to estimate AUC. The t1/2 was not calculated for the 45 µg/kg arm because there were insufficient data in terminal phase of serum concentration profiles. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'description': 'Participants received SPI-2012 45 µg/kg, subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'FG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'FG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'FG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'Evaluable Population', 'comment': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Initiation of Non-Protocol Therapy Either for Progressive Disease or Intolerance of TC Regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Need for Chemotherapy or Chemotherapy Regimen was Changed due to Amended HER2 Status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participant Refused Further Treatment or Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 27 investigative sites in the United States (10 sites), Australia (5 sites), Georgia (2 sites), Hungary (5 sites), Israel (1 site), and Poland (4 sites) from 25 March 2013 to 12 August 2014.', 'preAssignmentDetails': 'A total of 148 participants were randomized in the study, out of which 138 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: SPI-2012 45 µg/kg and TC', 'description': 'Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'BG001', 'title': 'Arm 2: SPI-2012 135 µg/kg and TC', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'BG002', 'title': 'Arm 3: SPI-2012 270 µg/kg and TC', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'BG003', 'title': 'Arm 4: Pegfilgrastim and TC', 'description': 'Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '11.31', 'groupId': 'BG000'}, {'value': '56.8', 'spread': '10.63', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '9.79', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '10.43', 'groupId': 'BG003'}, {'value': '58.2', 'spread': '10.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2020-01-23', 'completionDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2012-10-24', 'dispFirstSubmitQcDate': '2020-01-23', 'resultsFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2012-11-07', 'dispFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-22', 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Severe Neutropenia (DSN) in Cycle 1', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 1.'}], 'secondaryOutcomes': [{'measure': 'Duration of DSN in Cycle 2', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 2.'}, {'measure': 'Duration of DSN in Cycle 3', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 3.'}, {'measure': 'Duration of DSN in Cycle 4', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \\<0.5\\*10\\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\\> 2.0\\*10\\^9/L in Cycle 4.'}, {'measure': 'Time to ANC Recovery in Cycle 1', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10\\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 1."}, {'measure': 'Time to ANC Recovery in Cycle 2', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 2."}, {'measure': 'Time to ANC Recovery in Cycle 3', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 3."}, {'measure': 'Time to ANC Recovery in Cycle 4', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': "Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\\^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\\^9/L within Cycle 4."}, {'measure': 'Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.'}, {'measure': 'Absolute ANC Nadir Overtime in Cycle 2', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.'}, {'measure': 'Absolute ANC Nadir Overtime in Cycle 3', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.'}, {'measure': 'Absolute ANC Nadir Overtime in Cycle 4', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Mean ANC nadir was defined as the mean of the lowest ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.'}, {'measure': 'Depth of ANC Nadir in Cycle 1', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1.'}, {'measure': 'Depth of ANC Nadir in Cycle 2', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2.'}, {'measure': 'Depth of ANC Nadir in Cycle 3', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3.'}, {'measure': 'Depth of ANC Nadir in Cycle 4', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Depth of ANC nadir was defined as the lowest Median ANC value (\\*10\\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4.'}, {'measure': 'Time to ANC Nadir in Cycle 1', 'timeFrame': 'Cycle 1 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.'}, {'measure': 'Time to ANC Nadir in Cycle 2', 'timeFrame': 'Cycle 2 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.'}, {'measure': 'Time to ANC Nadir in Cycle 3', 'timeFrame': 'Cycle 3 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.'}, {'measure': 'Time to ANC Nadir in Cycle 4', 'timeFrame': 'Cycle 4 (each cycle was 21 days)', 'description': 'Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir.'}, {'measure': 'Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4', 'timeFrame': 'Cycle 1 to Cycle 4 (each cycle was 21 days)', 'description': 'FN was defined as a temperature of more than 38.2 degree Celsius (°C) concurrent with an ANC greater than 0.5×10\\^9/L..'}, {'measure': 'Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities', 'timeFrame': 'From the first dose up to 30 days post last dose of study drug (up to 4 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Participants with SAE other than death were reported.AE and Laboratory Abnormalities ("Hematology and Chemistry") were collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated and Grade 4 refers to life-threatening consequences; urgent intervention indicated.'}, {'measure': 'Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4', 'timeFrame': 'All cycles from Cycle 1 to Cycle 4 (each cycle was 21 days)'}, {'measure': 'Number of Participants With Positive Antibodies for SPI-2012', 'timeFrame': 'Up to the end of the study (Approximately 3.5 months)', 'description': 'Serum samples were to be tested in a screening assay for antibodies binding to SPI-2012 using a validated enzyme-linked immunosorbent assay (ELISA). Any serum samples positive for the antibody were to be tested in a confirmatory competitive inhibition assay using two antigens, SPI-2012 or granulocyte colony-stimulating factor (G-CSF), to confirm the presence of antibodies binding to SPI-2012 and to identify samples that were positive for antibodies binding to G-CSF.'}, {'measure': 'Time to Reach Maximum Concentration of SPI-2012 (Tmax)', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive pharmacokinetic (PK) parameters.'}, {'measure': 'Maximum Concentration of SPI-2012 (Cmax)', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.'}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312)', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 'AUC(0-312) is the area under the serum concentration-time curve from time zero to 312 hour post dose calculated by the linear trapezoidal rule. Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.'}, {'measure': 'Half-life of SPI-2012 (t1/2)', 'timeFrame': 'Pre-dose and at 1, 3, 6, 8, 10, 24, 48, 72, 144, 192, and 312 hours post-dose in Cycle 1 (each cycle was 21 days)', 'description': 't1/2 data were calculated and reported as harmonic mean and pseudo standard deviation (SD). Blood samples were collected at specific time points to determine the serum concentrations of SPI-2012 and to derive PK parameters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neutropenia']}, 'referencesModule': {'references': [{'pmid': '29573207', 'type': 'DERIVED', 'citation': 'Vacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.', 'detailedDescription': 'This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012 in participants with breast cancer. This study included four arms comprising three dose levels of SPI-2012 (Arm 1: 45 µg/kg, Arm 2: 135 µg/kg, Arm 3: 270 µg/kg) versus pegfilgrastim (Arm 4: 6 mg). The start of study is defined as the initiation of treatment with SPI-2012 or pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles (21 days per cycle) beginning on Day 1 with chemotherapy administration and continue through Day 21, plus a 30-day follow-up period, unless any of the discontinuation criteria applies.\n\nThe target population are participants with breast cancer who are candidates for neoadjuvant or adjuvant treatment with Docetaxel + Cyclophosphamide (TC) chemotherapy. All participants who receive at least 1 dose of either SPI-2012 or pegfilgrastim were followed for safety through 30 days after their last dose of study treatment or until all treatment-related adverse events (AEs) have resolved or returned to baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy\n* Candidate for docetaxel and cyclophosphamide chemotherapy\n* Female or male at least 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1.5×109/L\n* Platelet count ≥ 100 x 10\\^9/L\n* Creatinine ≤ 1.5 x upper limit of normal (ULN)\n* Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).\n* Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN\n* Hemoglobin \\> 9 g/dL\n* Alkaline phosphatase ≤ 1.5 x ULN\n\nExclusion Criteria:\n\n* Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered\n* Known Human Immunodeficiency Virus (HIV) infection\n* Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease\n* Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment\n* Prior bone marrow or stem cell transplant\n* Prolonged exposure to glucocorticosteroids and immunosuppressive agents'}, 'identificationModule': {'nctId': 'NCT01724866', 'briefTitle': 'Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (HM10460A) or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen', 'orgStudyIdInfo': {'id': 'SPI-GCF-12-201'}, 'secondaryIdInfos': [{'id': '2013-003094-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'description': 'Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 milligram/ square metre (mg/m\\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'interventionNames': ['Drug: SPI-2012', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'description': 'Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'interventionNames': ['Drug: SPI-2012', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'description': 'Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'interventionNames': ['Drug: SPI-2012', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)', 'description': 'Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows:\n\nDocetaxel 75 mg/m\\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\\^2 IV infusion over 30-60 minutes.', 'interventionNames': ['Drug: Pegfilgrastim', 'Drug: Docetaxel', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'SPI-2012', 'type': 'DRUG', 'otherNames': ['Rolontis®', 'HM10460A', 'Eflapegrastim'], 'description': 'SPI-2012 SC injection.', 'armGroupLabels': ['Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Pegfilgrastim', 'type': 'DRUG', 'otherNames': ['Neulasta®'], 'description': "Pegfilgrastim SC injection, per manufacturer's Prescribing Information.", 'armGroupLabels': ['Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel given based on standard dose for chemotherapy.', 'armGroupLabels': ['Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'Cyclophosphamide given based on standard dose for chemotherapy.', 'armGroupLabels': ['Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)', 'Arm 4: 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': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Desert Springs Cancer Care', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research and Excellence', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92346', 'city': 'Highland', 'state': 'California', 'country': 'United States', 'facility': 'Beaver Medical Group', 'geoPoint': {'lat': 34.12834, 'lon': -117.20865}}, {'zip': '92025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research and Excellence', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '41701', 'city': 'Hazard', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Cancer Clinic', 'geoPoint': {'lat': 37.24954, 'lon': -83.19323}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology, PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11733', 'city': 'Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Hematology/Oncology Associates', 'geoPoint': {'lat': 40.9351, 'lon': -73.11844}}, {'zip': '97330', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'Good Samaritan Hospital, Corvallis', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Frankston Hospital', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '7000', 'city': 'Brisbane', 'country': 'Australia', 'facility': 'Royal Hobart', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5037', 'city': 'Kurralta Park', 'country': 'Australia', 'facility': 'Ashford Cancer Center Research', 'geoPoint': {'lat': -34.95142, 'lon': 138.56702}}, {'zip': '6000', 'city': 'Perth', 'country': 'Australia', 'facility': 'Breast Cancer Research Center, WA', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '3355', 'city': 'Wendouree', 'country': 'Australia', 'facility': 'Ballarat Oncology & Haematology', 'geoPoint': {'lat': -37.53078, 'lon': 143.82838}}, {'zip': '6000', 'city': 'Batumi', 'country': 'Georgia', 'facility': 'LTD " Cancer Center of Adjara Autonomic Republic"', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': "Ltd ' Medulla - 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