Viewing Study NCT02712320

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Ignite Creation Date: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2026-01-24 @ 9:00 AM
Study NCT ID: NCT02712320
Status: COMPLETED
Last Update Posted: 2019-03-26
First Post: 2016-02-22
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.mao@foreseepharma.com', 'phone': '+886 2-2655-2658', 'title': 'Dr. John Mao', 'organization': 'Foresee Pharmaceuticals Co., Ltd.'}, 'certainAgreement': {'otherDetails': 'All information from the trial is property of the Sponsor and the PI has no right on it except the prior writing authorization of the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Perforated ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Drug-related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Event (SAE)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Evaluate the Effect of LMIS 50 mg on Cardiovascular Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'classes': [{'title': 'Overall Interpretation at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Overall Interpretation on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Overall Interpretation on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.'}, {'type': 'PRIMARY', 'title': 'Laboratory Assessments - Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'classes': [{'title': 'Hemoglobin (gm/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin (gm/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin (gm/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'RBC (x10.e6/uL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'RBC (x10.e6/uL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'RBC (x10.e6/uL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'WBC (x10.e3/uL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'WBC (x10.e3/uL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'WBC (x10.e3/uL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelets (x10.e3/uL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelets (x10.e3/uL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelets (x10.e3/uL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils(%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils(%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils(%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils(%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils(%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils(%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Basophils (%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Basophils (%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Basophils (%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes (%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes (%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes (%) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes (%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HgbA1c (%) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HgbA1c (%) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal-No clinical significance', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Abnormal-Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.'}, {'type': 'PRIMARY', 'title': 'Laboratory Assessments - Biochemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'classes': [{'title': 'ALT (U/L) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT (U/L) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT (U/L) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST (U/L) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST (U/L) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST (U/L) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP (U/L) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALP (U/L) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP (U/L) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin(mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin(mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin(mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BUN (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BUN (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BUN (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum Cr. (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum Cr. (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serum Cr. (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium (mEq/L) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium (mEq/L) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium (mEq/L) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium (mEq/L) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium (mEq/L) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium (mEq/L) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'LDL (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDL (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDL (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HDL (mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HDL (mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HDL (mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides(mg/dL) at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides(mg/dL) on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides(mg/dL) on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Abnormal - Clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.'}, {'type': 'PRIMARY', 'title': 'Laboratory Assessments - Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'classes': [{'title': 'pH at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'pH on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'pH on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Leukocyte at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Leukocyte on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocyte on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocyte at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocyte on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocyte on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Protein at Screening (V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Protein on Day 168 (V4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Protein on Day 336 (V6/EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Abnormal - No clinical significance', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Transferred to another facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Treating with the prohibited medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'All subjects were males with advanced prostate carcinoma that completed 12 months (48-week) of therapy with Leuprolide Mesylate Injectable Suspension (LMIS) 50 mg under the Protocol FP01C-13-001 and were suitable candidates for continued medical androgen ablation therapy as judged by investigators.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LMIS 50 mg', 'description': 'All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)\n\nLMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'spread': '7.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-22', 'size': 711444, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-15T02:52', 'hasProtocol': False}, {'date': '2015-10-01', 'size': 7307791, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-15T03:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2016-02-22', 'resultsFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-16', 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 48 weeks', 'description': 'Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events'}, {'measure': 'Evaluate the Effect of LMIS 50 mg on Cardiovascular Function', 'timeFrame': 'Up to 48 weeks', 'description': 'Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.'}, {'measure': 'Laboratory Assessments - Hematology', 'timeFrame': '48 weeks', 'description': 'Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.'}, {'measure': 'Laboratory Assessments - Biochemistry', 'timeFrame': '48 weeks', 'description': 'Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.'}, {'measure': 'Laboratory Assessments - Urinalysis', 'timeFrame': '48 weeks', 'description': 'Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Neoplasm Cancer Carcinoma', 'Safety Extension'], 'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.', 'detailedDescription': 'This is a multi-center, open-label, single-arm safety extension study. After completing 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose under Protocol FP01C-13-001 approximately 6 months prior to Day 0 or Protocol FP01C-13-001-EX) and providing a written informed consent, subjects will be screened against baseline inclusion/exclusion criteria necessary for study eligibility. Eligible subjects will receive LMIS 50 mg from the prefilled syringes (without dilution or other mixing) in up to two single subcutaneous injections given 6 months apart.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained.\n2. Laboratory values\n\n * Absolute neutrophil count ≥ 1,500 cells/µL\n * Platelets≥100,000 cells/µL\n * Hemoglobin ≥ 10 gm/dL\n * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n * Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN\n * Alanine Aminotransferase (ALT/SGPT) ≤ 2.5 × ULN\n * Serum creatinine ≤ 1.5 mg/dL\n * Lipid profile within acceptable range according to investigator's opinion\n * Serum glucose within acceptable range according to investigator's opinion\n * HgbA1c within acceptable range according to investigator's opinion\n * Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment\n * Urinalysis within normal range according to the investigator's judgment\n3. Agree to use male contraceptive methods during study trial\n4. In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol\n5. All aspects of the protocol explained and written informed consent obtained \\*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated.\n\nIf the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests\n\nExclusion Criteria:\n\n1. Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study.\n2. Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001\n3. Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001.\n4. Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject\n5. Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg\n6. Subjects with persistent, non-castrate testosterone levels judged by the investigator\n7. Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor"}, 'identificationModule': {'nctId': 'NCT02712320', 'briefTitle': 'Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Foresee Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma - SAFETY EXTENSION', 'orgStudyIdInfo': {'id': 'FP01C-13-001-EX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMIS 50 mg', 'description': '50 mg leuprolide mesylate administered subcutaneously, when given as two separate injections 6 months apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)', 'interventionNames': ['Drug: LMIS 50 mg']}], 'interventions': [{'name': 'LMIS 50 mg', 'type': 'DRUG', 'description': 'Subcutaneous injection of 50 mg Leuprolide Mesylate', 'armGroupLabels': ['LMIS 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Research, LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Urologic Institute - Meridian', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AdvanceMed Research', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Trials, LLC', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Urology Research Center', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}], 'overallOfficials': [{'name': 'John Mao, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Foresee Pharmaceuticals Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foresee Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'QPS-Qualitix', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}