Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01328158
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2011-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abvj-pmos@abbvie.com', 'phone': '+81-3-4577-1125', 'title': 'AbbVie Japan PMOS Desk', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated', 'otherNumAtRisk': 220, 'otherNumAffected': 99, 'seriousNumAtRisk': 220, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'SYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'SKIN PAPILLOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': "BASEDOW'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DYSLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERPHOSPHATASAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LIPID METABOLISM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPO HDL CHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CERVICOBRACHIAL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CONJUNCTIVITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CORNEAL EROSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CHORIORETINOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DEAFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CONGESTIVE CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HEPATIC FUNCTION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LIVER DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DRUG-INDUCED LIVER INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LIPODYSTROPHY ACQUIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'POLYARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'OSTEOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CALCULUS URINARY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'RENAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'GYNAECOMASTIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BETA 2 MICROGLOBULIN URINE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD TRIGLYCERIDES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD URIC ACID INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'C-REACTIVE PROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'GLUCOSE URINE PRESENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LIPIDS ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LOW DENSITY LIPOPROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'RED BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'WHITE BLOOD CELL COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PROTEIN URINE PRESENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}], 'seriousEvents': [{'term': 'AMOEBIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CHRONIC HEPATITIS C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LYMPH NODE TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'MYCOBACTERIUM AVIUM COMPLEX INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ENTERITIS INFECTIOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HEPATITIS VIRUS-ASSOCIATED NEPHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HERPES ZOSTER MENINGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ANAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'HEPATIC CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'LARGE INTESTINE POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'BILIARY COLIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'THREATENED LABOUR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'categories': [{'measurements': [{'value': '37.73', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'number of adverse drug reaction', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Male (n=205)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Female (n=15)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absence of pregnancy (n=10)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Presence of pregnancy (n=5)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': '≤ 14 Years (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '15 Years to ≤ 29 Years (n=10)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '30 Years to ≤ 49 Years (n=158)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': '50 years to ≤ 64 Years (n=43)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': '≥ 65 Years (n=8)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Inpatient (n=2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Outpatient (n=191)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Switching between Inpatient and Outpatient (n=27)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=10)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=210)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Japanese (n=204)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=16)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Blood Product (n=17)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Mother-to-Child Transmission (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Medical Accident (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (n=179)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=24)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': '≤ 1 Year (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 Year to ≤ 2 Years (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '2 Years to ≤ 3 Years (n=2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Years to ≤ 4 Years (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 Years to ≤ 5 Years (n=2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '>5 Years (n=10)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=205)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=77)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=137)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=6)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=135)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=67)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=18)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=52)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=168)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=217)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=159)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=61)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Hepatitis Present (n=49)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=203)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Haemophilia A: Present (n=11)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Haemophilia B: Present (n=6)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Without Hepatitis C (n=3)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'With Hepatitis C (n=14)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'A (n=9)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'B (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'C (n=5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'P-0 (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'P-1 (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'P-2 (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=206', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': '2 Tabs × 2 Times/Day (n=156)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': '4 Tabs × 1 Time/Day (n=56)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '2 × 2 Changing to 4 x 1 Tabs x Times/Day (n=5)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Switch Between 2x2 and 4x1 Tabs x Times/Day (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other (3 Tabs x 2 Times as Other Daily Dose) (n=2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': '< Lopinavir 800/Ritonavir 200 mg (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lopinavir 800/Ritonavir 200 mg (n=217)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': '> Lopinavir 800/Ritonavir 200 mg (n=3)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': '≤ 30 Days (n=5)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '31 Days to ≤ 180 Days (n=27)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '181 Days to ≤ 364 Days (n=19)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '≥ 365 Days (n=168)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Unknown/Undescribed (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=220)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=206)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=14)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'NRTIs (n=214', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'NNRTIs (n=9)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Integrase Inhibitors (n=11)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'CCR5 Inhibitors (n=0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown". Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Absent (n=104)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Present (n=116)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 Months', 'description': 'A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Use Duration: 0 Months (n=6)', 'categories': [{'measurements': [{'value': '144.5', 'spread': '130.9', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 3 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 6 Months (n=1)', 'categories': [{'measurements': [{'value': '190.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 9 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 12 Months (n=1)', 'categories': [{'measurements': [{'value': '104.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 24 Months (n=3)', 'categories': [{'measurements': [{'value': '184.3', 'spread': '225.4', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 36 Months (n=2)', 'categories': [{'measurements': [{'value': '330.0', 'spread': '200.8', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 48 Months (n=1)', 'categories': [{'measurements': [{'value': '474.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 60 Months (n=1)', 'categories': [{'measurements': [{'value': '377.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.'}, {'type': 'SECONDARY', 'title': 'Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Use Duration: 0 Months (n=4)', 'categories': [{'measurements': [{'value': '654.5', 'spread': '280.4', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 3 Months (n=1)', 'categories': [{'measurements': [{'value': '657.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 6 Months (n=1)', 'categories': [{'measurements': [{'value': '835.0', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 9 Months (n=2)', 'categories': [{'measurements': [{'value': '713.5', 'spread': '82.7', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 12 Months (n=2)', 'categories': [{'measurements': [{'value': '878.5', 'spread': '229.8', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 24 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 36 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 48 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 60 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.'}, {'type': 'SECONDARY', 'title': 'Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Use Duration: 0 Months (n=6)', 'categories': [{'measurements': [{'value': '5.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 3 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 6 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 9 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 12 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 24 Months (n=3)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 36 Months (n=2)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 48 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 60 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.'}, {'type': 'SECONDARY', 'title': 'Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'Use Duration: 0 Months (n=4)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 3 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 6 Months (n=1)', 'categories': [{'measurements': [{'value': '2.6', 'spread': 'NA', 'comment': 'Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 9 Months (n=2)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 12 Months (n=2)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 24 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 36 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 48 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'Use Duration: 60 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each CDC Classification Category of HIV-infection Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir: Baseline CDC Category A', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}, {'id': 'OG001', 'title': 'Lopinavir/Ritonavir: Baseline CDC Category C', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}, {'id': 'OG002', 'title': 'Lopinavir/Ritonavir: Baseline CDC Category Unknown', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'CDC Category A After Treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'CDC Category B After Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'CDC Category C After Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'CDC Category Unknown After Treatment', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Month 60 after first dose of Lopinavir/Ritonavir', 'description': 'CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'At 0 Months (n=6)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'At 3 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'AT 9 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'At 12 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 24 Months (n=3)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'At 36 Months (n=2)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 48 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 60 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'classes': [{'title': 'At 0 Months (n=4)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 3 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months (n=1)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 9 Months (n=2)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 12 Months (n=2)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'At 24 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'At 36 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'At 48 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}, {'title': 'At 60 Months (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data available for assessment.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Survey forms were collected from 236 patients. 16 participants completed treatment with Lopinavir/Ritonavir tablets before the start of enrollment in this study and were excluded from the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence/Absence of Previous Treatment of HIV-Infection', 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2011-04-01', 'resultsFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-12', 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Drug Reactions', 'timeFrame': 'Up to 60 Months', 'description': 'Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Adverse Drug Reactions', 'timeFrame': 'Up to 60 Months', 'description': 'Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown". Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.'}, {'measure': 'Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs', 'timeFrame': 'Up to 60 Months', 'description': 'Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'Up to 60 Months', 'description': 'A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.'}, {'measure': 'Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir'}, {'measure': 'Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir'}, {'measure': 'Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.'}, {'measure': 'Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.'}, {'measure': 'Number of Participants in Each CDC Classification Category of HIV-infection Over Time', 'timeFrame': 'Up to Month 60 after first dose of Lopinavir/Ritonavir', 'description': 'CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants', 'timeFrame': 'Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir', 'description': 'Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \\< 400 copies/mL, the result was recorded as 399 copies/mL.'}]}, 'conditionsModule': {'keywords': ['Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection'], 'conditions': ['Human Immunodeficiency Virus Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:\n\n1. Incidence and conditions of occurrence of adverse reactions in the clinical setting\n2. Factors that may affect the safety and effectiveness of Kaletra (QD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.\n\nExclusion Criteria:\n\n* Participants with a history of hypersensitivity to any ingredient of this drug.\n* Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.'}, 'identificationModule': {'nctId': 'NCT01328158', 'briefTitle': 'Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection', 'orgStudyIdInfo': {'id': 'P12-760'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lopinavir/Ritonavir', 'description': 'Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57629', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57630', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57631'}, {'city': 'Kitakyushu-shi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57628'}, {'city': 'Kurashiki-shi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57638'}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57634', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57625', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57626', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57637', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Nishinomiya-shi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57632'}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57639', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57640', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57636', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 48722', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57641', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57643', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57644', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57645', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57646', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57647', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57648', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57650', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 57633', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Susumu Adachi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie G.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}