Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02650193
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2016-01-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately Day 94', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cycle 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cycle 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arachnoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cerebral atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3900.482', 'spread': '683.6870', 'groupId': 'OG000'}, {'value': '5880.985', 'spread': '1287.2887', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': 'hour*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.'}, {'type': 'PRIMARY', 'title': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1425862.2', 'spread': '949518.8', 'groupId': 'OG000'}, {'value': '5689476.1', 'spread': '3757035.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).', 'unitOfMeasure': 'hour*picogram per milliliter (h*pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Serum Concentration (Cmax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '38026.7', 'spread': '28821.7', 'groupId': 'OG000'}, {'value': '155766.7', 'spread': '99051.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Duration of Severe Neutropenia (DSN): Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.667', 'spread': '0.9847', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC \\< 0.5 x10\\^9/L).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure."}, {'type': 'PRIMARY', 'title': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '10084193.7', 'spread': '14047222.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '6017621.6', 'spread': '5920395.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '118130.8', 'spread': '119028.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '95200.0', 'spread': '93544.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.512', 'spread': '6.0710', 'groupId': 'OG000'}, {'value': '43.257', 'spread': '5.5683', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': '*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.950', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '144.10'}, {'value': '47.800', 'groupId': 'OG001', 'lowerLimit': '46.90', 'upperLimit': '48.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.'}, {'type': 'SECONDARY', 'title': 'Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1749.523', 'spread': '1022.3037', 'groupId': 'OG000'}, {'value': '2752.198', 'spread': '2152.8794', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'hour*cells per microliter (h*cells/ mcL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.'}, {'type': 'SECONDARY', 'title': 'Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.970', 'spread': '6.8536', 'groupId': 'OG000'}, {'value': '27.343', 'spread': '18.4805', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'cells per microliter (cells/mcL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.000', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '96.10'}, {'value': '96.600', 'groupId': 'OG001', 'lowerLimit': '95.80', 'upperLimit': '191.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. 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Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5254.288', 'spread': '1699.7088', 'groupId': 'OG000'}, {'value': '6576.165', 'spread': '1821.9919', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': 'hour*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1835.221', 'spread': '1036.6473', 'groupId': 'OG000'}, {'value': '3159.470', 'spread': '2197.4774', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'hour*cells per microliter (h*cells/mcL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm. Here "Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1410202.6', 'spread': '948443.5', 'groupId': 'OG000'}, {'value': '5677700.3', 'spread': '3756049.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '12'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Elimination Half-Life (t1/2): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 't1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Elimination Rate Constant (λz): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'spread': '0.0051', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.0041', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Elimination rate constant was defined as the rate at which the drug was removed from the body.', 'unitOfMeasure': 'per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4235.6', 'spread': '4714.4', 'groupId': 'OG000'}, {'value': '1655.9', 'spread': '1242.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.', 'unitOfMeasure': 'milliliter per hour (mL/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1440264.8', 'spread': '959109.9', 'groupId': 'OG000'}, {'value': '5689476.1', 'spread': '3757035.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1424447.1', 'spread': '958023.7', 'groupId': 'OG000'}, {'value': '5677700.3', 'spread': '3756049.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '38410.8', 'spread': '29112.8', 'groupId': 'OG000'}, {'value': '155766.7', 'spread': '99051.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Duration of Severe Neutropenia (DSN): Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.667', 'spread': '0.9847', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9/L. DSN was defined as the days with grade 4 neutropenia (ANC \\< 0.5 x10\\^9/L).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, \'Overall number of participants analyzed" signifies number of participants evaluable for the specified outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '1.132', 'spread': '1.1480', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '1.623', 'spread': '1.8364', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.', 'unitOfMeasure': '*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Time of ANC Nadir Concentration: Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '129.231', 'spread': '23.0585', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '142.154', 'spread': '65.3323', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '2540.285', 'spread': '854.2237', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '3186.542', 'spread': '1362.0079', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': "ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': 'hour*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5636.963', 'spread': '1974.1635', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12399.370', 'spread': '18345.3366', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", 'unitOfMeasure': 'hour*10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. Here, "number analyzed" field signifies that the number of participants were evaluable at specified time point.'}, {'type': 'SECONDARY', 'title': 'Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (\\>) 38.5 °C for \\>1 hour and ANC less than (\\<) 1.0 \\*10\\^9/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Neutropenia: Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Time to ANC Recovery: Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '2.615', 'spread': '1.7097', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '2.000', 'spread': '1.633', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (\\>=) 2.0 x10\\^9/L after any day with ANC \\<2.0 x10\\^9/L.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10093213.5', 'spread': '14047936.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6425013.3', 'spread': '6000938.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' field signifies that the number of participants were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '48'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '142'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Elimination Half-Life (t1/2): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '9.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 't1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Elimination Rate Constant (λz): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.0099', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.0060', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Elimination rate constant was defined as the rate at which the drug was removed from the body.', 'unitOfMeasure': 'per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1326.8', 'spread': '1010.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2342.8', 'spread': '2043.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points."}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '10087666.8', 'spread': '14045724.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '6045733.4', 'spread': '5955438.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10096698.3', 'spread': '14046434.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6454443.8', 'spread': '6037499.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable at the specified timepoints only."}, {'type': 'SECONDARY', 'title': 'Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '118173.0', 'spread': '119004.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '95670.1', 'spread': '94209.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Vital Sign Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Physical Examination Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Clinically significant abnormality was based upon investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With At Least 1 Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Exposure to Study Drug Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '3.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '6.00'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately Day 94', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Positive Anti-pegfilgrastim (Anti-drug) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'OG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to approximately Day 94', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'FG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'FG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cycle 0: HSP-130 3mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'BG001', 'title': 'Cycles 0: HSP-130 6mg', 'description': 'Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'BG002', 'title': 'Cycles 1-4: HSP-130 6mg', 'description': 'Participants in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Participants were followed approximately 30 days after last dose of study treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '8.89', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '13.60', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '8.95', 'groupId': 'BG002'}, {'value': '59.3', 'spread': '10.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who received at least 1 dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-22', 'size': 7088678, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-21T11:10', 'hasProtocol': True}, {'date': '2017-12-11', 'size': 1183378, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-21T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-21', 'studyFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the 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/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) of Special Interest', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis.'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Baseline up to approximately Day 94', 'description': 'Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).'}, {'measure': 'Number of Participants With Clinically Significant Vital Sign Abnormalities', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion."}, {'measure': 'Number of Participants With Clinically Significant Physical Examination Abnormalities', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator's discretion."}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to approximately Day 94', 'description': "Clinically significant abnormality was based upon investigator's discretion."}, {'measure': 'Number of Participants With At Least 1 Concomitant Medication', 'timeFrame': 'Baseline up to approximately Day 94'}, {'measure': 'Duration of Exposure to Study Drug Medication', 'timeFrame': 'Baseline up to approximately Day 94'}, {'measure': 'Number of Participants With Positive Anti-pegfilgrastim (Anti-drug) Antibodies', 'timeFrame': 'Baseline up to approximately Day 94'}], 'primaryOutcomes': [{'measure': 'Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).'}, {'measure': 'Maximum Observed Serum Concentration (Cmax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Duration of Severe Neutropenia (DSN): Cycle 1', 'timeFrame': 'Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC \\< 0.5 x10\\^9/L).'}, {'measure': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).'}, {'measure': 'Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).'}, {'measure': 'Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Elimination Half-Life (t1/2): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 't1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.'}, {'measure': 'Elimination Rate Constant (λz): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Elimination rate constant was defined as the rate at which the drug was removed from the body.'}, {'measure': 'Apparent Clearance (CL/F): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.'}, {'measure': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).'}, {'measure': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).'}, {'measure': 'Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0', 'timeFrame': 'Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).'}, {'measure': 'Duration of Severe Neutropenia (DSN): Cycle 4', 'timeFrame': 'Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9/L. DSN was defined as the days with grade 4 neutropenia (ANC \\< 0.5 x10\\^9/L).'}, {'measure': 'Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.'}, {'measure': 'Time of ANC Nadir Concentration: Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.'}, {'measure': 'Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': "ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': "Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood."}, {'measure': 'Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (\\>) 38.5 °C for \\>1 hour and ANC less than (\\<) 1.0 \\*10\\^9/L.'}, {'measure': 'Incidence of Severe Neutropenia: Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose', 'description': 'Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \\< 0.5 x10\\^9/L.'}, {'measure': 'Time to ANC Recovery: Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (\\>=) 2.0 x10\\^9/L after any day with ANC \\<2.0 x10\\^9/L.'}, {'measure': 'Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).'}, {'measure': 'Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose'}, {'measure': 'Elimination Half-Life (t1/2): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 't1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.'}, {'measure': 'Elimination Rate Constant (λz): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'Elimination rate constant was defined as the rate at which the drug was removed from the body.'}, {'measure': 'Apparent Clearance (CL/F): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).'}, {'measure': 'Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).'}, {'measure': 'Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4', 'timeFrame': 'Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose', 'description': 'The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HSP-130 Phase 1-2 Study in patients with Breast cancer'], 'conditions': ['Non-metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34618197', 'type': 'DERIVED', 'citation': 'Yao HM, Jones SR, Morales S, Moosavi S, Zhang J, Freyman A, Ottery FD. Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer. Cancer Chemother Pharmacol. 2021 Dec;88(6):1033-1048. doi: 10.1007/s00280-021-04355-6. Epub 2021 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of how one or more injections of HSP-130 under the skin effect the white blood cell counts and drug levels in women with breast cancer that has not spread to distant sites in the body (non-metastatic). This will be studied in women before breast surgery or while receiving chemotherapy. Safety will also be studied.\n\nAdditionally, the purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials.', 'detailedDescription': 'This is an open-label, sequential enrollment study characterizing the pharmacodynamic (PD), pharmacokinetic (PK) and safety of HSP-130 in subjects with non-metastatic breast cancer who have not previously received chemotherapy at any point prior to enrollment in this study (ZIN-130-1504).\n\nThe purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials.\n\nThere are two aspects of the study. In the initial part of the study, 6 subjects will be sequentially enrolled to receive HSP-130 treatment (3 mg , or 6 mg by subcutaneous injection) during the period between biopsy and definitive surgery. This will determine whether 3 mg and 6 mg have similar or different effects on the PD variables (absolute neutrophil counts and CD34+ cell counts). This part of the study is referred to as Cycle 0 since study subjects will receive no chemotherapy while receiving HSP-130 until the effect of HSP-130 on the PD variables is known. A total of 12 subjects may be enrolled in Cycle 0.\n\nThe objective of Cycle 1-4 is to determine the dose to be taken forward to Phase 3 clinical trials. Cycles 1-4 subjects will receive HSP-130 after their definitive breast surgery at the time they receive TAC chemotherapy (docetaxel, doxorubicin, and cyclophosphamide). Subjects will receive up to 4 cycles of every 3 week TAC chemotherapy with HSP-130 given on Day 2 of the chemotherapy regimen.\n\n* If the 3 mg dose is found to be inferior (potentially subtherapeutic) to the 6 mg dose in Cycle 0, only the 6 mg dose will be studied in Cycles 1-4 (n=12), when subjects receive concomitant chemotherapy.\n* If the 3 mg dose is found to be comparable to the PD results obtained in Cycle 0 with 6 mg, the 3 mg dose (n=12) will also be studied in women receiving TAC chemotherapy.\n\nData from the HSP-130 6 mg regimen (plus 3 mg, as appropriate) will be analysed, discussed with the FDA and determination if a dose greater than 6 mg is appropriate to study (e.g., 12 mg). If all three doses are studied, a total enrollment of up to 36 subjects is projected for Cycles 1-4.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A subject will be eligible for study participation if all of the following criteria are met at Screening:\n\n 1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities\n 2. Females ≥ 18 years\n 3. Histologically confirmed and documented invasive breast cancer\n 4. Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up\n 5. Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy\n 6. Zubrod/WHO/ECOG performance status ≤ 2\n 7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:\n\n 1. Hemoglobin ≥ 10 mg/dl\n 2. ANC ≥ 1.5 x 10\\^9/L\n 3. Platelet count of ≥ 100 x 10\\^9/L\n 4. Total bilirubin ≤ 2 mg/dl\n 5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) of the reference lab\n 6. Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≥ 60 mg/min\n 8. Body mass index (BMI) of 19 to 40 kg/m\\^2 , inclusive\n 9. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study\n\n Medically acceptable forms of birth control can include, with approval of the treating physician:\n 1. Barrier methods (condom or diaphragm with spermicide)\n 2. Intrauterine device (IUD)\n 3. Hormone contraceptives (such as oral \\[pill\\], injection, skin patch, implant, cervical ring)\n 4. Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit\n 10. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study\n\nExclusion Criteria:\n\n* A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:\n\n 1. Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF\n 2. Prior autologous stem cell harvest of any type\n 3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents\n 4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin\n 5. For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction\n 6. Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years\n 7. Known HER2 + ( overexpressing breast cancer)\n 8. Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer\n 9. ≥ Grade 2 underlying neuropathy\n 10. Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections\n 11. Treatment with systemically active antibiotics within 72 hours before chemotherapy\n 12. Known infection with HIV\n 13. Known sickle cell disease\n 14. Known severe persistent drug-induced myelosuppression\n 15. New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130\n 16. Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130\n 17. Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product\n 18. Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study\n 19. Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130\n 20. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication'}, 'identificationModule': {'nctId': 'NCT02650193', 'briefTitle': 'A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1-2 Ascending Dose Study To Assess The Pharmacodynamics, Pharmacokinetics, And Safety Of Hsp-130 In Subjects With Non-metastatic Breast Cancer Following Single-dose And Multiple-dose Administration By Subcutaneous Injection', 'orgStudyIdInfo': {'id': 'ZIN-130-1504'}, 'secondaryIdInfos': [{'id': 'C1221002', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2015-002057-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSP-130', 'description': 'Cycle 0:\n\nRegimen A: HSP 130, 3 mg, single SC injection in the deltoid region (n = 6) Regimen B: HSP 130, 6 mg, single SC injection in the deltoid region (n = 6)\n\nCycles 1-4:\n\nRegimen B (n = 12): HSP 130, 6 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4.\n\nPotential Regimen A (n = 12): 3 mg with background chemotherapy: Inclusion of this cohort will be based on assessment of comparability between Regimens A and B in Cycle 0 for ANC and CD34+ as defined above. If performed, this regimen will be HSP 130, 3 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4, as appropriate.\n\nConditional Regimen C (12 mg):This cohort will not be initiated until data from cycle 0 for 3 mg and 6 mg and Cycles 1-4 for 6 mg has been reviewed and analyzed.', 'interventionNames': ['Drug: HSP-130']}], 'interventions': [{'name': 'HSP-130', 'type': 'DRUG', 'otherNames': ['Pegylated filgrastim'], 'description': 'Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg', 'armGroupLabels': ['HSP-130']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3529', 'city': 'Miskolc', 'state': 'BAZ Megye', 'country': 'Hungary', 'facility': 'CRU Hungary Kft.,CRU Early Phase Unit, Miskolci Semmelweis Kórház és Egyetemi Oktató Kórház', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdú-bihar Megye', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Központ, ÁOK, Onkológiai Klinika', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Országos Onkológiai Intézet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '25198', 'city': 'Lleida', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitario Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28942', 'city': 'Fuenlanbrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Fuenlabrada, Servicio de oncologia'}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'START Madrid - CIOCC, Unidad de fases 1 planta 3, Hospital Universitario HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova. planta 6, unidad de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospira, now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}