Viewing Study NCT00450333

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Ignite Creation Date: 2025-12-25 @ 2:47 AM
Ignite Modification Date: 2025-12-31 @ 3:01 AM
Study NCT ID: NCT00450333
Status: TERMINATED
Last Update Posted: 2021-06-14
First Post: 2007-03-21
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Dynepo Infrequent Dosing Study
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'C516023', 'term': 'epoetin delta'}], 'ancestors': [{'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': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)', 'otherNumAtRisk': 98, 'otherNumAffected': 59, 'seriousNumAtRisk': 98, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)', 'otherNumAtRisk': 107, 'otherNumAffected': 50, 'seriousNumAtRisk': 107, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)', 'otherNumAtRisk': 100, 'otherNumAffected': 44, 'seriousNumAtRisk': 100, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)', 'otherNumAtRisk': 102, 'otherNumAffected': 44, 'seriousNumAtRisk': 102, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperphosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain stem hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intercranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthopnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'OG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)'}, {'id': 'OG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)'}, {'id': 'OG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)'}], 'timeFrame': 'Baseline and 24 weeks', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'OG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)'}, {'id': 'OG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)'}, {'id': 'OG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)'}], 'timeFrame': 'week 16 and 24', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrits at 16 and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'OG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)'}, {'id': 'OG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)'}, {'id': 'OG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)'}], 'timeFrame': 'Baseline and Weeks 16 and 24', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'FG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)'}, {'id': 'FG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)'}, {'id': 'FG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Kidney transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.', 'preAssignmentDetails': 'Erythropoietin (EPO)-naive subjects were randomized to receive Dynepo (Epoetin delta) once weekly (QW) or twice weekly (BIW) and subjects who were already stable on EPO (doses \\< or equal to 10,000 IU/week) were randomized to receive Dynepo once every 2 weeks (Q2W) or once weekly.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '407', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dynepo (Epoetin Delta)-Naive Once-weekly (QW)', 'description': 'Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'BG001', 'title': 'Dynepo-naive Twice-weekly (BIW)', 'description': 'EPO-naive subjects receiving Epoetin delta twice weekly (BIW)'}, {'id': 'BG002', 'title': 'Dynepo Once Every 2 Weeks (Q2W)', 'description': 'EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)'}, {'id': 'BG003', 'title': 'Dynepo QW', 'description': 'EPO stable subjects receiving Epoetin delta once weekly (QW)'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '14.97', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '12.45', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '13.86', 'groupId': 'BG002'}, {'value': '65.5', 'spread': '16.04', 'groupId': 'BG003'}, {'value': '65.7', 'spread': '14.33', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '247', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'whyStopped': "The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2008-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-10', 'studyFirstSubmitDate': '2007-03-21', 'resultsFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2007-03-21', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-09-29', 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL', 'timeFrame': 'week 16 and 24', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}, {'measure': 'Change From Baseline in Hematocrits at 16 and 24 Weeks', 'timeFrame': 'Baseline and Weeks 16 and 24', 'description': 'This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic'], 'conditions': ['Anemia', 'Kidney Failure']}, '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': '17999759', 'type': 'DERIVED', 'citation': 'Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \\[KDOQI\\] stage III-V).\n* Stable on and taking doses \\<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.\n* Transferrin saturation \\>= 20% and ferritin \\>= 100 ng/mL.\n\nExclusion Criteria:\n\n* Uncontrolled hypertension.\n* Requiring doses of EPO \\> 10,000 IU/week.\n* Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.\n* Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).\n* Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.\n* Androgen therapy in the 30 days immediately prior to randomisation in the study.\n* Known Human Immunodeficiency Virus(HIV)infection.\n* History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.'}, 'identificationModule': {'nctId': 'NCT00450333', 'briefTitle': 'Dynepo Infrequent Dosing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis', 'orgStudyIdInfo': {'id': 'SPD490-301'}, 'secondaryIdInfos': [{'id': '2006-002052-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Erythropoietin(EPO)-naive BIW', 'interventionNames': ['Drug: Dynepo (Epoetin delta)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'EPO-naive QW', 'interventionNames': ['Drug: Dynepo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'EPO QW', 'interventionNames': ['Drug: Dynepo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'EPO Q2W', 'interventionNames': ['Drug: Dynepo']}], 'interventions': [{'name': 'Dynepo (Epoetin delta)', 'type': 'DRUG', 'description': 'subcutaneous, BIW for 24 weeks', 'armGroupLabels': ['1']}, {'name': 'Dynepo', 'type': 'DRUG', 'description': 'subcutaneous, QW for 24 weeks', 'armGroupLabels': ['2']}, {'name': 'Dynepo', 'type': 'DRUG', 'description': 'subcutaneous, QW for 24 weeks', 'armGroupLabels': ['3']}, {'name': 'Dynepo', 'type': 'DRUG', 'description': 'subcutaneous, Q2W for 24 weeks', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8036', 'city': 'Graz', 'state': 'Steiemark', 'country': 'Austria', 'facility': 'Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Univ.-Klinik für Innere Medizin/Klin. 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