Viewing Study NCT01227395

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Ignite Creation Date: 2025-12-24 @ 2:04 PM
Ignite Modification Date: 2025-12-27 @ 9:31 PM
Study NCT ID: NCT01227395
Status: COMPLETED
Last Update Posted: 2013-04-26
First Post: 2010-10-07
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
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': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The frequency of treatment related advers events during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.', 'otherNumAtRisk': 391, 'otherNumAffected': 62, 'seriousNumAtRisk': 391, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.', 'otherNumAtRisk': 84, 'otherNumAffected': 6, 'seriousNumAtRisk': 84, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Lipodystrophy acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Sexual dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Beta 2 microglobulin urine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}], 'seriousEvents': [{'term': 'Progressive multifocal leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Duodenal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With the Frequency of Treatment Related Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No statistical analysis provided for the frequency of treatment related adverse events.'}, {'type': 'PRIMARY', 'title': 'Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '<65 Years', 'description': 'Participants with \\<65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': '>=65 Years', 'description': 'Participants with \\>=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.696', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Age". The null hypothesis is there is no difference between "\\<65 years and \\>=65 years " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \\<65 years or \\>=65 years is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.334', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Gender". The null hypothesis is there is no difference between "Male and Female " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin With Concomitant Drugs', 'description': 'Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin Without Concomitant Drugs', 'description': 'Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=1.000', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "concomitant drugs". The null hypothesis is there is no difference between "with and without concomitant drugs " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin With Renal Dysfunction', 'description': 'Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin Without Renal Dysfunction', 'description': 'Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=1.000', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Renal Dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin With Allergies', 'description': 'Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin Without Allergies', 'description': 'Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.015', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Allergies". The null hypothesis is there is no difference between "with and without allergies" in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '<65 Years', 'description': 'Participants with \\<65 years who taking Azithromycin for Treatment according to Japanese Package Insert.'}, {'id': 'OG001', 'title': '>=65 Years', 'description': 'Participants with \\>=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=1.000', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Age". The null hypothesis is there is no difference between "\\<65 years and \\>=65 years " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \\<65 years or \\>=65 years is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.290', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Gender". The null hypothesis is there is no difference between "Male and Female " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin With Renal Dysfunction', 'description': 'Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin Without Renal Dysfunction', 'description': 'Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Renal Dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction " in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin With Allergies', 'description': 'Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.'}, {'id': 'OG001', 'title': 'Azithromycin Without Allergies', 'description': 'Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.707', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'The risk factor tested was "Allergies". The null hypothesis is there is no difference between "with and without allergies" in the frequency of Treatment Related Adverse Events(TRAEs).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Responded to Azithromycin Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Prevented by Azithromycin Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 years(MAX)', 'description': 'The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'FG001', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '391'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '391'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin for Prophylaxis', 'description': 'Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.'}, {'id': 'BG001', 'title': 'Azithromycin for Treatment', 'description': 'Participants taking Azithromycin for Treatment according to Japanese Package Insert.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '381', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2010-10-07', 'resultsFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-04', 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With the Frequency of Treatment Related Adverse Events.', 'timeFrame': '9 years(MAX)', 'description': 'Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.'}, {'measure': 'Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.', 'timeFrame': '9 years(MAX)', 'description': 'Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \\<65 years or \\>=65 years is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \\<65 years or \\>=65 years is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.'}, {'measure': 'Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).', 'timeFrame': '9 years(MAX)', 'description': 'Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Responded to Azithromycin Treatment.', 'timeFrame': '9 years(MAX)', 'description': 'The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.'}, {'measure': 'Number of Participants Prevented by Azithromycin Treatment.', 'timeFrame': '9 years(MAX)', 'description': 'The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Post Marketing Surveillance'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.', 'detailedDescription': 'All the patients whom an investigator prescribes the first Zithromac Tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects whom an investigator involving A0661097 prescribes the Azithromycin Tablets 600mg (Zithromac Tablets 600mg).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.\n\nExclusion Criteria:\n\nPatients not administered Zithromac Tablets 600mg.'}, 'identificationModule': {'nctId': 'NCT01227395', 'briefTitle': 'Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (Post Marketing Commitment Plan)', 'orgStudyIdInfo': {'id': 'A0661097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Azithromycin', 'description': 'Patients taking Azithromycin.', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromac, Zithromax, Azithromycin'], 'description': 'Inhibition of onset: Perorally administer 1200mg of azithromycin (potency) once a week to adults.\n\nTreatment: Perorally administer 600mg of azithromycin (potency) once a day to adults.', 'armGroupLabels': ['Azithromycin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Altmarc Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}