Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00701805
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2008-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form.', 'description': 'Adverse events were reported for all subjects who received at least 1 dose of paricalcitol during the study, which included 2 additional subjects who were not included in the efficacy analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'otherNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'otherNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 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0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Shunt infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Shunt aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spondylolithesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Participants With of Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '40.74', 'groupId': 'OG000'}, {'value': '63.33', 'groupId': 'OG001'}, {'value': '60.87', 'groupId': 'OG002'}, {'value': '65.38', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anytime during the study through Week 53', 'description': 'The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \\> 11.5 mg/dL or at least 2 consecutive adjusted calcium \\>= 11.0 mg/dL during the 52 weeks of the study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study.'}, {'type': 'PRIMARY', 'title': 'The Percentage of Participants With Hyperphosphatemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '40.74', 'groupId': 'OG000'}, {'value': '36.67', 'groupId': 'OG001'}, {'value': '26.09', 'groupId': 'OG002'}, {'value': '38.46', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anytime during the study through Week 53', 'description': 'The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \\>= 7.0 mg/dL during the 52 weeks of the study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study.'}, {'type': 'SECONDARY', 'title': 'The Mean Change in Intact Parathyroid Hormone (iPTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '-263.7', 'groupId': 'OG000', 'lowerLimit': '-342.59', 'upperLimit': '-184.80'}, {'value': '-223.3', 'groupId': 'OG001', 'lowerLimit': '-295.58', 'upperLimit': '-151.11'}, {'value': '-248.3', 'groupId': 'OG002', 'lowerLimit': '-308.16', 'upperLimit': '-188.36'}, {'value': '-173.3', 'groupId': 'OG003', 'lowerLimit': '-345.37', 'upperLimit': '-1.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)', 'unitOfMeasure': 'picograms/milliliter (pg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': "The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'title': 'Subjects with iPTH <= 180 pg/mL', 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}, {'value': '39.1', 'groupId': 'OG002'}, {'value': '38.5', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with decrease in iPTH >= 50%', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}, {'value': '56.5', 'groupId': 'OG002'}, {'value': '57.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '96.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change in Mean iPTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '517.7', 'spread': '208.90', 'groupId': 'OG000'}, {'value': '502.5', 'spread': '158.02', 'groupId': 'OG001'}, {'value': '510.9', 'spread': '110.73', 'groupId': 'OG002'}, {'value': '519.7', 'spread': '191.00', 'groupId': 'OG003'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '543.5', 'spread': '227.63', 'groupId': 'OG000'}, {'value': '548.2', 'spread': '186.89', 'groupId': 'OG001'}, {'value': '527.7', 'spread': '126.04', 'groupId': 'OG002'}, {'value': '623.2', 'spread': '250.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '472.5', 'spread': '214.50', 'groupId': 'OG000'}, {'value': '478.8', 'spread': '189.24', 'groupId': 'OG001'}, {'value': '408.0', 'spread': '120.17', 'groupId': 'OG002'}, {'value': '490.3', 'spread': '254.65', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '463.4', 'spread': '219.02', 'groupId': 'OG000'}, {'value': '451.8', 'spread': '198.15', 'groupId': 'OG001'}, {'value': '337.0', 'spread': '130.90', 'groupId': 'OG002'}, {'value': '381.3', 'spread': '233.11', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '363.7', 'spread': '226.01', 'groupId': 'OG000'}, {'value': '378.9', 'spread': '228.00', 'groupId': 'OG001'}, {'value': '286.8', 'spread': '123.40', 'groupId': 'OG002'}, {'value': '291.7', 'spread': '237.20', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '356.6', 'spread': '250.28', 'groupId': 'OG000'}, {'value': '312.4', 'spread': '204.53', 'groupId': 'OG001'}, {'value': '251.6', 'spread': '97.55', 'groupId': 'OG002'}, {'value': '236.0', 'spread': '192.90', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '292.4', 'spread': '246.21', 'groupId': 'OG000'}, {'value': '244.7', 'spread': '183.57', 'groupId': 'OG001'}, {'value': '222.6', 'spread': '109.80', 'groupId': 'OG002'}, {'value': '228.8', 'spread': '194.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '255.0', 'spread': '213.14', 'groupId': 'OG000'}, {'value': '200.4', 'spread': '157.93', 'groupId': 'OG001'}, {'value': '198.1', 'spread': '110.03', 'groupId': 'OG002'}, {'value': '242.2', 'spread': '172.47', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '241.5', 'spread': '213.32', 'groupId': 'OG000'}, {'value': '185.3', 'spread': '145.92', 'groupId': 'OG001'}, {'value': '200.0', 'spread': '89.35', 'groupId': 'OG002'}, {'value': '242.5', 'spread': '152.77', 'groupId': 'OG003'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '245.1', 'spread': '226.00', 'groupId': 'OG000'}, {'value': '193.0', 'spread': '139.02', 'groupId': 'OG001'}, {'value': '203.7', 'spread': '99.57', 'groupId': 'OG002'}, {'value': '291.5', 'spread': '225.08', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '232.3', 'spread': '192.04', 'groupId': 'OG000'}, {'value': '219.7', 'spread': '155.85', 'groupId': 'OG001'}, {'value': '231.6', 'spread': '136.57', 'groupId': 'OG002'}, {'value': '247.5', 'spread': '238.10', 'groupId': 'OG003'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '253.6', 'spread': '160.57', 'groupId': 'OG000'}, {'value': '251.8', 'spread': '170.12', 'groupId': 'OG001'}, {'value': '246.2', 'spread': '146.08', 'groupId': 'OG002'}, {'value': '240.8', 'spread': '216.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '237.7', 'spread': '161.57', 'groupId': 'OG000'}, {'value': '267.1', 'spread': '200.43', 'groupId': 'OG001'}, {'value': '277.3', 'spread': '192.73', 'groupId': 'OG002'}, {'value': '266.2', 'spread': '193.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '268.6', 'spread': '205.67', 'groupId': 'OG000'}, {'value': '282.6', 'spread': '192.29', 'groupId': 'OG001'}, {'value': '312.4', 'spread': '205.30', 'groupId': 'OG002'}, {'value': '329.1', 'spread': '236.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '264.2', 'spread': '165.97', 'groupId': 'OG000'}, {'value': '317.3', 'spread': '193.50', 'groupId': 'OG001'}, {'value': '359.4', 'spread': '198.28', 'groupId': 'OG002'}, {'value': '357.4', 'spread': '243.67', 'groupId': 'OG003'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '260.3', 'spread': '150.59', 'groupId': 'OG000'}, {'value': '345.2', 'spread': '242.46', 'groupId': 'OG001'}, {'value': '338.2', 'spread': '172.23', 'groupId': 'OG002'}, {'value': '368.9', 'spread': '290.14', 'groupId': 'OG003'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '235.3', 'spread': '153.17', 'groupId': 'OG000'}, {'value': '314.9', 'spread': '209.30', 'groupId': 'OG001'}, {'value': '332.9', 'spread': '169.80', 'groupId': 'OG002'}, {'value': '357.0', 'spread': '297.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '226.4', 'spread': '133.54', 'groupId': 'OG000'}, {'value': '301.0', 'spread': '188.52', 'groupId': 'OG001'}, {'value': '314.0', 'spread': '100.02', 'groupId': 'OG002'}, {'value': '307.8', 'spread': '233.98', 'groupId': 'OG003'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '238.5', 'spread': '190.65', 'groupId': 'OG000'}, {'value': '309.3', 'spread': '212.15', 'groupId': 'OG001'}, {'value': '315.4', 'spread': '106.45', 'groupId': 'OG002'}, {'value': '323.7', 'spread': '207.68', 'groupId': 'OG003'}]}]}, {'title': 'Week 25', 'categories': [{'measurements': [{'value': '207.1', 'spread': '159.00', 'groupId': 'OG000'}, {'value': '298.7', 'spread': '207.91', 'groupId': 'OG001'}, {'value': '307.9', 'spread': '137.16', 'groupId': 'OG002'}, {'value': '349.4', 'spread': '246.98', 'groupId': 'OG003'}]}]}, {'title': 'Week 27', 'categories': [{'measurements': [{'value': '233.8', 'spread': '154.92', 'groupId': 'OG000'}, {'value': '293.6', 'spread': '193.28', 'groupId': 'OG001'}, {'value': '271.7', 'spread': '117.34', 'groupId': 'OG002'}, {'value': '349.3', 'spread': '277.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 29', 'categories': [{'measurements': [{'value': '233.4', 'spread': '169.07', 'groupId': 'OG000'}, {'value': '267.7', 'spread': '173.87', 'groupId': 'OG001'}, {'value': '270.9', 'spread': '161.03', 'groupId': 'OG002'}, {'value': '306.4', 'spread': '217.70', 'groupId': 'OG003'}]}]}, {'title': 'Week 31', 'categories': [{'measurements': [{'value': '241.3', 'spread': '148.54', 'groupId': 'OG000'}, {'value': '287.9', 'spread': '151.70', 'groupId': 'OG001'}, {'value': '257.1', 'spread': '132.29', 'groupId': 'OG002'}, {'value': '285.7', 'spread': '209.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 33', 'categories': [{'measurements': [{'value': '238.8', 'spread': '151.08', 'groupId': 'OG000'}, {'value': '293.9', 'spread': '175.41', 'groupId': 'OG001'}, {'value': '263.2', 'spread': '122.00', 'groupId': 'OG002'}, {'value': '319.7', 'spread': '285.10', 'groupId': 'OG003'}]}]}, {'title': 'Week 35', 'categories': [{'measurements': [{'value': '242.4', 'spread': '154.48', 'groupId': 'OG000'}, {'value': '290.7', 'spread': '150.82', 'groupId': 'OG001'}, {'value': '227.3', 'spread': '109.73', 'groupId': 'OG002'}, {'value': '336.0', 'spread': '231.41', 'groupId': 'OG003'}]}]}, {'title': 'Week 37', 'categories': [{'measurements': [{'value': '277.7', 'spread': '155.17', 'groupId': 'OG000'}, {'value': '294.7', 'spread': '176.56', 'groupId': 'OG001'}, {'value': '267.6', 'spread': '144.44', 'groupId': 'OG002'}, {'value': '299.8', 'spread': '241.77', 'groupId': 'OG003'}]}]}, {'title': 'Week 39', 'categories': [{'measurements': [{'value': '275.5', 'spread': '156.20', 'groupId': 'OG000'}, {'value': '316.0', 'spread': '218.05', 'groupId': 'OG001'}, {'value': '236.9', 'spread': '124.05', 'groupId': 'OG002'}, {'value': '296.7', 'spread': '298.52', 'groupId': 'OG003'}]}]}, {'title': 'Week 41', 'categories': [{'measurements': [{'value': '224.0', 'spread': '119.93', 'groupId': 'OG000'}, {'value': '304.6', 'spread': '163.90', 'groupId': 'OG001'}, {'value': '239.1', 'spread': '108.72', 'groupId': 'OG002'}, {'value': '242.4', 'spread': '115.27', 'groupId': 'OG003'}]}]}, {'title': 'Week 43', 'categories': [{'measurements': [{'value': '249.8', 'spread': '145.48', 'groupId': 'OG000'}, {'value': '319.4', 'spread': '188.02', 'groupId': 'OG001'}, {'value': '277.9', 'spread': '117.03', 'groupId': 'OG002'}, {'value': '246.2', 'spread': '105.05', 'groupId': 'OG003'}]}]}, {'title': 'Week 45', 'categories': [{'measurements': [{'value': '247.7', 'spread': '148.75', 'groupId': 'OG000'}, {'value': '279.4', 'spread': '171.65', 'groupId': 'OG001'}, {'value': '251.5', 'spread': '88.42', 'groupId': 'OG002'}, {'value': '204.3', 'spread': '96.70', 'groupId': 'OG003'}]}]}, {'title': 'Week 47', 'categories': [{'measurements': [{'value': '250.2', 'spread': '162.72', 'groupId': 'OG000'}, {'value': '272.0', 'spread': '160.91', 'groupId': 'OG001'}, {'value': '204.2', 'spread': '70.13', 'groupId': 'OG002'}, {'value': '240.2', 'spread': '162.50', 'groupId': 'OG003'}]}]}, {'title': 'Week 49', 'categories': [{'measurements': [{'value': '271.0', 'spread': '183.26', 'groupId': 'OG000'}, {'value': '277.7', 'spread': '212.64', 'groupId': 'OG001'}, {'value': '221.3', 'spread': '102.75', 'groupId': 'OG002'}, {'value': '294.5', 'spread': '213.57', 'groupId': 'OG003'}]}]}, {'title': 'Week 51', 'categories': [{'measurements': [{'value': '278.0', 'spread': '180.69', 'groupId': 'OG000'}, {'value': '295.0', 'spread': '214.96', 'groupId': 'OG001'}, {'value': '267.5', 'spread': '165.72', 'groupId': 'OG002'}, {'value': '283.0', 'spread': '212.41', 'groupId': 'OG003'}]}]}, {'title': 'Week 53', 'categories': [{'measurements': [{'value': '258.6', 'spread': '173.45', 'groupId': 'OG000'}, {'value': '254.8', 'spread': '143.86', 'groupId': 'OG001'}, {'value': '252.7', 'spread': '163.02', 'groupId': 'OG002'}, {'value': '281.4', 'spread': '221.18', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every week from Baseline through Week 13 and every other week thereafter until Week 53', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of 2 Consecutive Decreases in iPTH >= 50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '94.13', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '34.51', 'groupId': 'OG001'}, {'value': '47.2', 'spread': '62.98', 'groupId': 'OG002'}, {'value': '30.2', 'spread': '32.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Duration of 2 Consecutive iPTH Values <= 180 pg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '50.58', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '20.15', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '24.35', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '33.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Percentage of Participants With Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '22.22', 'groupId': 'OG000'}, {'value': '43.30', 'groupId': 'OG001'}, {'value': '30.43', 'groupId': 'OG002'}, {'value': '46.15', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anytime from Week 13 through Week 53', 'description': 'The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \\> 11.5 mg/dL or at least 2 consecutive adjusted calcium \\>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'OG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'FG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'FG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'FG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Missed 7 consecutive doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Admitted to hospital for 2 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician decision, change of therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Difficult to travel to dialysis site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Resumption criteria were not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.', 'preAssignmentDetails': 'One of the 107 subjects withdrew consent before receiving study drug in this study. 106 subjects were treated with study drug. Two of these subjects were not included in the Full Analysis Set for analysis of efficacy because of subject death (n = 1) and withdrawal of consent (n = 1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'BG001', 'title': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'BG002', 'title': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'id': 'BG003', 'title': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment."}, {'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': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '11.89', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '12.06', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '12.14', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '11.91', 'groupId': 'BG003'}, {'value': '60.6', 'spread': '11.90', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-18', 'studyFirstSubmitDate': '2008-06-17', 'resultsFirstSubmitDate': '2010-12-28', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-18', 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Percentage of Participants With Hypercalcemia', 'timeFrame': 'Anytime from Week 13 through Week 53', 'description': 'The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \\> 11.5 mg/dL or at least 2 consecutive adjusted calcium \\>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)'}], 'primaryOutcomes': [{'measure': 'The Percentage of Participants With of Hypercalcemia', 'timeFrame': 'Anytime during the study through Week 53', 'description': 'The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \\> 11.5 mg/dL or at least 2 consecutive adjusted calcium \\>= 11.0 mg/dL during the 52 weeks of the study.'}, {'measure': 'The Percentage of Participants With Hyperphosphatemia', 'timeFrame': 'Anytime during the study through Week 53', 'description': 'The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \\>= 7.0 mg/dL during the 52 weeks of the study.'}], 'secondaryOutcomes': [{'measure': 'The Mean Change in Intact Parathyroid Hormone (iPTH)', 'timeFrame': 'From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)'}, {'measure': "The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit", 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)"}, {'measure': 'The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%', 'timeFrame': "Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)"}, {'measure': 'Change in Mean iPTH', 'timeFrame': 'Every week from Baseline through Week 13 and every other week thereafter until Week 53'}, {'measure': 'Duration of 2 Consecutive Decreases in iPTH >= 50%', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)"}, {'measure': 'Duration of 2 Consecutive iPTH Values <= 180 pg/mL', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)"}, {'measure': 'The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)"}, {'measure': 'The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit', 'timeFrame': "From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Secondary hyperparathyroidism', 'Hemodialysis', 'paricalcitol'], 'conditions': ['Secondary Hyperparathyroidism', 'Hemodialysis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=12632', 'label': 'prescribing information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).', 'detailedDescription': 'The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who completed 12 weeks of Study M10-309 (NCT00667576).\n\nExclusion Criteria:\n\n* Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.\n* Patients with progressive malignancy or clinically significant hepatic disease.\n* Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).\n* Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).'}, 'identificationModule': {'nctId': 'NCT00701805', 'briefTitle': 'Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': 'M10-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paricalcitol 2 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': 'Paricalcitol 2 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': 'Paricalcitol 4 µg ± 1 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': 'Paricalcitol 4 µg ± 2 µg', 'description': "Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.", 'interventionNames': ['Drug: Paricalcitol']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.', 'armGroupLabels': ['Paricalcitol 2 µg ± 1 µg', 'Paricalcitol 2 µg ± 2 µg', 'Paricalcitol 4 µg ± 1 µg', 'Paricalcitol 4 µg ± 2 µg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Moriaki KUBO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott Japan Co.,Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Yoshihiko Ueki', 'oldOrganization': 'Abbott'}}}}