Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT01473420
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2011-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, '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': {'description': 'Same event may appear as both AE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).', 'otherNumAtRisk': 80, 'otherNumAffected': 16, 'seriousNumAtRisk': 80, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).', 'otherNumAtRisk': 86, 'otherNumAffected': 10, 'seriousNumAtRisk': 86, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).', 'otherNumAtRisk': 122, 'otherNumAffected': 27, 'seriousNumAtRisk': 122, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).', 'otherNumAtRisk': 122, 'otherNumAffected': 24, 'seriousNumAtRisk': 122, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Procedural Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eosinophil Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arteriovenous Fistula Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Graft Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Limb Traumatic Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Uterine Leiomyoma', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vulval Cancer', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vulval Cancer Stage 0', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Menorrhagia', 'notes': 'This event was gender specific.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aneurysm Ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.17', 'spread': '0.821', 'groupId': 'OG000'}, {'value': '10.11', 'spread': '0.838', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.104', 'groupDescription': 'Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 30 up to Week 34', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Intent-to-treat (ITT) population included all participants who were randomized into the maintenance period.'}, {'type': 'PRIMARY', 'title': 'Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '82.07', 'spread': '95.517', 'groupId': 'OG000'}, {'value': '79.14', 'spread': '82.264', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.34', 'ciLowerLimit': '-14.51', 'ciUpperLimit': '9.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.175', 'groupDescription': 'LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 30 up to Week 34', 'unitOfMeasure': 'unit per kilogram per week (U/kg/week)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.20', 'spread': '0.625', 'groupId': 'OG000'}, {'value': '10.22', 'spread': '0.665', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8338', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Two-sample t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "Number of Participants Analyzed" (N) signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '81.93', 'spread': '93.824', 'groupId': 'OG000'}, {'value': '75.08', 'spread': '72.174', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6895', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'U/kg/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Total Dose of Study Medication Administered: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '102003.2', 'spread': '135560.52', 'groupId': 'OG000'}, {'value': '86478.5', 'spread': '83351.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9177', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 19 up to Week 34', 'description': 'In this outcome measure mean of total dose of study medication administered in maintenance period was reported.', 'unitOfMeasure': 'units of study medication', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 34', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, 34', 'description': 'Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '62.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 34', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26, 34', 'description': 'Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 up to Week 18', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in maintenance period. Safety analysis population for titration period included all participants who received at least 1 dose of study treatment in titration period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Blood Transfusions: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Dose Decrease: Hb <9.0 g/dL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Dose Decrease: Hb (9.0 to 11.0 g/dL)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Dose Decrease: Hb >11.0 g/dL', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Dose Increase: Hb <9.0 g/dL', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Dose Increase: Hb (9.0 to 11.0 g/dL)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Dose Increase: Hb >11.0 g/dL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 19 up to Week 34', 'description': 'In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \\>11.0 g/dL, from 9.0 to 11.0 g/dL and \\<9.0 g/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG001', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 19 up to Week 34', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With General Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Excellent Tolerability', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}, {'value': '63.9', 'groupId': 'OG002'}, {'value': '50.8', 'groupId': 'OG003'}]}]}, {'title': 'Good Tolerability', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}, {'value': '27.9', 'groupId': 'OG003'}]}]}, {'title': 'Mild Intolerability', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '16.4', 'groupId': 'OG003'}]}]}, {'title': 'Moderate Intolerability', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Severe Intolerability', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Local Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Epoetin Hospira: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to this study, were titrated and optimally stabilized to receive SC injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG001', 'title': 'Epogen: Titration Period', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18).'}, {'id': 'OG002', 'title': 'Epoetin Hospira: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epoetin Hospira at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'OG003', 'title': 'Epogen: Maintenance Period', 'description': 'During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'classes': [{'title': 'Excellent Tolerability', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '66.3', 'groupId': 'OG001'}, {'value': '67.2', 'groupId': 'OG002'}, {'value': '54.1', 'groupId': 'OG003'}]}]}, {'title': 'Good Tolerability', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}, {'value': '30.3', 'groupId': 'OG003'}]}]}, {'title': 'Mild Intolerability', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}, {'value': '9.0', 'groupId': 'OG003'}]}]}, {'title': 'Moderate Intolerability', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '3.3', 'groupId': 'OG003'}]}]}, {'title': 'Severe Intolerability', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Epoetin Hospira', 'description': 'During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'FG001', 'title': 'Epogen', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}], 'periods': [{'title': 'Titration Period (18 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Did not meet criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}]}, {'title': 'Maintenance Period (16 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not meet criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Kidney transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Started Peritoneal Dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Long term hospitalization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Elevated Hemoglobin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with chronic renal failure were receiving Epoetin maintenance therapy prior to enrollment and treatment in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Epoetin Hospira', 'description': 'During titration period participants who were on Epogen intravenous (IV) regimen prior to this study, were titrated and optimally stabilized to receive subcutaneous (SC) injection of Epoetin Hospira. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose of study treatment was adjusted to maintain hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epoetin Hospira at optimal dose demonstrated in titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'BG001', 'title': 'Epogen', 'description': 'During titration period participants who were on Epogen IV regimen prior to enrollment in this study, were titrated and optimally stabilized to receive SC injection of Epogen. Participants who were on Epogen SC regimen prior to this study were continued to receive same as a part of routine clinical practice and did not receive any study treatment during titration period. Dose was adjusted to maintain the Hb level from 9 to 11 g/dL. Drug was administered 1 to 3 times per week in titration period (Week 1 to Week 18). During maintenance period participants received SC injection of Epogen at the optimal dose demonstrated in the titration period 1 to 3 times per week up to 16 weeks (Week 19 to Week 34). Participants were followed up to 4 weeks after last dose of study treatment (up to Week 38).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all participants who were enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'dispFirstSubmitDate': '2015-02-23', 'completionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2011-11-02', 'dispFirstSubmitQcDate': '2015-02-23', 'resultsFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2011-11-16', 'dispFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-21', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant 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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).'}, {'measure': 'Number of Participants With Treatment Related Adverse Events (AEs)', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug.'}, {'measure': 'Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Physical Examination', 'timeFrame': 'Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38', 'description': 'Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.'}, {'measure': 'Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.'}, {'measure': 'Percentage of Participants With General Tolerability', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.'}, {'measure': 'Percentage of Participants With Local Tolerability', 'timeFrame': 'Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38', 'description': 'Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.'}], 'primaryOutcomes': [{'measure': 'Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period', 'timeFrame': 'Week 30 up to Week 34'}, {'measure': 'Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period', 'timeFrame': 'Week 30 up to Week 34'}], 'secondaryOutcomes': [{'measure': 'Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Total Dose of Study Medication Administered: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34', 'description': 'In this outcome measure mean of total dose of study medication administered in maintenance period was reported.'}, {'measure': 'Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period', 'timeFrame': 'Week 26, 34', 'description': 'Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.'}, {'measure': 'Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period', 'timeFrame': 'Week 26, 34', 'description': 'Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.'}, {'measure': 'Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period', 'timeFrame': 'Week 1 up to Week 18'}, {'measure': 'Percentage of Participants Who Received Blood Transfusions: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}, {'measure': 'Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34', 'description': 'In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \\>11.0 g/dL, from 9.0 to 11.0 g/dL and \\<9.0 g/dL'}, {'measure': 'Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period', 'timeFrame': 'Week 19 up to Week 34'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Renal Failure', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '36791280', 'type': 'DERIVED', 'citation': 'Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.'}, {'pmid': '32734207', 'type': 'DERIVED', 'citation': 'Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities\n2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply:\n\n * A change in Epogen dosing of no more than 10% from the mean\n * Mean hemoglobin between 9.0 and 11.0 g/dL\n * No more than one hemoglobin result outside of range from 9.0-11.0 g/dL\n * No hemoglobin result more than ±1 g/dL from the mean hemoglobin level\n3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer\n4. Patients with adequate iron stores, defined as plasma ferritin \\> 100 μg/L and TSAT \\>20%, prior to randomization\n5. Male or female patients aged 18 to 80 years (both inclusive)\n6. If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:\n\n * hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization\n * intrauterine device (IUD)\n * double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)\n\nIf hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last dose\n\nExclusion Criteria:\n\n1. Maintenance epoetin dosage \\>600 U/kg per week (1-3 times per week)\n2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization\n3. Any of the following within 3 months prior to randomization:\n\n * Myocardial infarction\n * Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction\n * Severe/unstable angina\n * Coronary angioplasty, bypass surgery, or peripheral artery bypass graft\n * Decompensated congestive heart failure (New York Heart Association \\[NYHA\\] class IV)\n * Pulmonary embolism\n * Deep vein thrombosis or other thromboembolic event\n * Received live or attenuated vaccination (except flu vaccination)\n4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures \\>170 mmHg systolic and/or \\>110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight\n5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)\n6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease\n7. Contraindication for the test drug or have been previously treated with Epoetin Hospira\n8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period\n9. Platelet count below 100 x 10\\^9/L\n10. Clinically relevant increase of CRP (\\>10 mg/dL) for at least 2 weeks\n11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation\n12. History of any of the following:\n\n * Detectable anti-rhEPO antibodies\n * Clinically relevant malnutrition\n * Confirmed aluminum intoxication\n * Myelodysplastic syndrome\n * Known bone marrow fibrosis (osteitis fibrosa cystica)\n * Known seizure disorder\n * Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)\n13. A female patient who is pregnant, lactating or planning a pregnancy during the study\n14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator\n15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization\n16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n17. Donated or lost \\>475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization\n18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit\n19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)"}, 'identificationModule': {'nctId': 'NCT01473420', 'acronym': 'AiME - 13', 'briefTitle': 'A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Subcutaneous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment', 'orgStudyIdInfo': {'id': 'EPOE-10-13'}, 'secondaryIdInfos': [{'id': 'C3461003', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epoetin Hospira', 'description': 'Epoetin Hospira', 'interventionNames': ['Biological: Epoetin Hospira']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epogen (Amgen)', 'description': 'Epogen (Amgen)', 'interventionNames': ['Biological: Epogen Amgen']}], 'interventions': [{'name': 'Epoetin Hospira', 'type': 'BIOLOGICAL', 'description': 'Variable dose', 'armGroupLabels': ['Epoetin Hospira']}, {'name': 'Epogen Amgen', 'type': 'BIOLOGICAL', 'otherNames': ['Epoetin Alfa'], 'description': 'Variable dose', 'armGroupLabels': ['Epogen (Amgen)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'National Institute of Clinical Research', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Dialysis Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Academic Medical Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95350', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Dialysis Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Dialysis Center of Northridge, LLC', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Renal Medical Group', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'facility': 'Research Management Inc.', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'Pleasanton Dialysis Center', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Sunset Dialysis Center', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Capital Nephrology Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Chabot Nephrology Medical Group', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'San Leandro Dialysis', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '91387', 'city': 'Santa Clarita', 'state': 'California', 'country': 'United States', 'facility': 'Renal Consultants Medical Group', 'geoPoint': {'lat': 34.39166, 'lon': -118.54259}}, {'zip': '90602', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Intercommunity Dialysis Center', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'American Institute of Research', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Whittier Kidney Dialysis Center', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80002', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Nephrology and Metabolic Bone Disease, PC', 'geoPoint': {'lat': 39.80276, 'lon': -105.08748}}, {'zip': '80031', 'city': 'Westminster', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kidney Center of Westminster, LLC', 'geoPoint': {'lat': 39.83665, 'lon': -105.0372}}, {'zip': '80031', 'city': 'Westminster', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Nephrology and Metabolic Bone Disease, PC', 'geoPoint': {'lat': 39.83665, 'lon': -105.0372}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Pines Clinical Research Inc.', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '31701-2057', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dialysis Clinic, Inc. - Albany', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kidney Care Associates', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31021', 'city': 'Dublin', 'state': 'Georgia', 'country': 'United States', 'facility': 'Renal Physicians of Georgia, PC', 'geoPoint': {'lat': 32.54044, 'lon': -82.90375}}, {'zip': '60636', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Neomedica Marquette Park', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research by Design, LLC', 'geoPoint': {'lat': 41.72059, 'lon': 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