Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT01023035
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2009-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'France', 'Germany', 'Italy', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ribavirin Dose Reduction Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.', 'otherNumAtRisk': 249, 'otherNumAffected': 247, 'seriousNumAtRisk': 249, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Erythropoietin Use Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.', 'otherNumAtRisk': 251, 'otherNumAffected': 248, 'seriousNumAtRisk': 251, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Treated/Not Randomized', 'description': 'Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \\>10 g/dL throughout the 28- or 48-week treatment period.', 'otherNumAtRisk': 187, 'otherNumAffected': 180, 'seriousNumAtRisk': 187, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 239, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 215, 'numAffected': 152}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 54, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 154, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 162, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 49, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 102, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 107, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 70, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 94, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 104, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 67, 'numAffected': 61}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 33, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 171, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 211, 'numAffected': 153}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 118, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 66, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 103, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 48, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 78, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 86, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 54, 'numAffected': 49}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 237, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 248, 'numAffected': 178}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 138, 'numAffected': 108}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 74, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 75, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 47, 'numAffected': 44}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 62, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 74, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 43, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 63, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 114, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 52, 'numAffected': 45}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 53, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 65, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 71, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 56, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 55, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 68, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 41, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 64, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 66, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 36, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disturbance in Attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 46, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 70, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 85, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 38, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 151, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 168, 'numAffected': 136}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 92, 'numAffected': 77}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Affect Lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 60, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 65, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 41, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 81, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 89, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 63, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 65, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 71, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 42, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 55, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 60, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 102, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 108, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 57, 'numAffected': 55}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 47, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 45, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 56, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 68, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 94, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 100, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 40, 'numAffected': 34}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash Generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cholelithiasis Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abscess Soft Tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Corneal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infected Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tubo-ovarian Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Multiple Drug Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Operative Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Snake Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Traumatic Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood Potassium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diabetes Melllitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthraliga', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metastases to Lymph Nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Toxic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'VIIth Nerve Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicidal Behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Adnexa Uteri Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombophlebitis Superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombosed Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ribavirin Dose Reduction Arm', 'description': 'After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.'}, {'id': 'OG001', 'title': 'Erythropoietin Use Arm', 'description': 'After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000'}, {'value': '70.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '7.2', 'groupDescription': 'The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.', 'statisticalMethod': 'Mantel-Haenszel, modified Koch method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Follow-up Week 24', 'description': 'SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management \\[FAS, n=500\\]).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ribavirin Dose Reduction Arm', 'description': 'After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.'}, {'id': 'OG001', 'title': 'Erythropoietin Use Arm', 'description': 'After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.'}, {'id': 'OG002', 'title': 'Treated/Not Randomized', 'description': 'Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \\>10 g/dL throughout the 28- or 48-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '35'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '40'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '56', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Study Day 1 up to Study Treatment Week 48', 'description': 'Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (\\<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification \\[LLQ\\] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants, defined as all participants who were treated with any study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ribavirin Dose Reduction Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.'}, {'id': 'FG001', 'title': 'Erythropoietin Use Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.'}, {'id': 'FG002', 'title': 'Treated/Not Randomized', 'description': 'Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \\>10 g/dL throughout the 28- or 48-week treatment period.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '166'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '118'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'Non-Medical Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '24'}]}]}, {'title': 'Follow-up Period (up to Week 72)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-medical Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '38'}]}]}], 'preAssignmentDetails': '687 Participants enrolled and were treated with Peginterferon/Ribavirin (PEG2b/RBV) followed by PEG2b/RBV + boceprevir. 500 participants became anemic during treatment and were randomized to either the RBV Dose Reduction Arm (n=249) or the Erythropoietin Use Arm (n=251).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '687', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ribavirin Dose Reduction Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.'}, {'id': 'BG001', 'title': 'Erythropoietin Use Arm', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.'}, {'id': 'BG002', 'title': 'Treated/Not Randomized', 'description': 'Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \\>10 g/dL throughout the 28- or 48-week treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '49.7', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '49.3', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '434', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 687}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2009-11-24', 'resultsFirstSubmitDate': '2012-10-16', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-10-16', 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR)', 'timeFrame': 'At Follow-up Week 24', 'description': 'SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Discontinued Treatment', 'timeFrame': 'From Study Day 1 up to Study Treatment Week 48', 'description': 'Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (\\<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification \\[LLQ\\] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '23924660', 'type': 'DERIVED', 'citation': 'Poordad F, Lawitz E, Reddy KR, Afdhal NH, Hezode C, Zeuzem S, Lee SS, Calleja JL, Brown RS Jr, Craxi A, Wedemeyer H, Nyberg L, Nelson DR, Rossaro L, Balart L, Morgan TR, Bacon BR, Flamm SL, Kowdley KV, Deng W, Koury KJ, Pedicone LD, Dutko FJ, Burroughs MH, Alves K, Wahl J, Brass CA, Albrecht JK, Sulkowski MS; Protocol 6086 Investigators. Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic hepatitis C virus genotype 1 infection--a randomized trial. Gastroenterology. 2013 Nov;145(5):1035-1044.e5. doi: 10.1053/j.gastro.2013.07.051. Epub 2013 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to efficacy. All participants in this trial will be treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes anemic during treatment, the participant will be randomized to one of two therapeutic strategies for management of anemia (erythropoietin use versus RBV dose reduction).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must have previously documented Chronic Hepatitis C (CHC) genotype 1 infection.\n* Hemoglobin concentration at Screening must be ≤15 g/dL for both females and males.\n* Participant must have a liver biopsy with histology consistent with CHC and no other etiology.\n* Participant with bridging fibrosis (F3) or cirrhosis (F4) must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma.\n* Participant's weight must be ≥40 kg and ≤125 kg.\n* Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.\n* Participant must be willing to give written informed consent.\n* Participant must be willing to attend frequent site visits for the duration of the trial.\n* Participant must not have any contraindications for the use of erythropoietin.\n\nExclusion Criteria:\n\n* Participants known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus.\n* Participants who received prior treatment for hepatitis C.\n* Treatment with any investigational drug within 30 days of the screening visit in this trial.\n* Participants receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam.\n* Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial.\n* Evidence of decompensated liver disease.\n* Diabetic and/or hypertensive participants with clinically significant ocular examination findings.\n* Pre-existing psychiatric condition(s).\n* Clinical diagnosis of substance abuse of specified drugs within specified timeframes.\n* Any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial.\n* Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).\n* Participants who are pregnant or nursing. Participants who intend to become pregnant during the trial period. Male participants with partners who are, or intend to become, pregnant during the trial period.\n* Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the trial.\n* Participant who had a life-threatening serious adverse event during the screening period.\n* A participant must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.\n* Protocol-specified hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements).\n* Serum albumin below the lower limit of normal (LLN) of laboratory reference range.\n* Thyroid-stimulating hormone (TSH) \\>1.2 x Upper Limit of Normal (ULN) or \\<0.8 x LLN of laboratory reference.\n* Serum creatinine \\>ULN of the laboratory reference.\n* Protocol-specified serum glucose concentrations.\n* Prothrombin time/partial thromboplastin time (PT/PTT) values \\>10% above laboratory reference range.\n* Protocol-specified alpha fetoprotein concentrations."}, 'identificationModule': {'nctId': 'NCT01023035', 'briefTitle': 'Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naive Subjects: A Comparison of Erythropoietin Use Versus Ribavirin Dose Reduction for the Management of Anemia', 'orgStudyIdInfo': {'id': 'P06086'}, 'secondaryIdInfos': [{'id': '2009-012782-63', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated/Not Randomized', 'description': 'Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \\>10 g/dL throughout the 28- or 48-week treatment period.', 'interventionNames': ['Drug: Boceprevir', 'Drug: Peginterferon alfa-2b (PEG2b)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Ribavirin Dose Reduction', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.', 'interventionNames': ['Drug: Boceprevir', 'Drug: Peginterferon alfa-2b (PEG2b)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Erythropoietin Use', 'description': 'After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.', 'interventionNames': ['Drug: Boceprevir', 'Drug: Peginterferon alfa-2b (PEG2b)', 'Drug: Ribavirin (RBV)', 'Drug: Erythropoietin']}], 'interventions': [{'name': 'Boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': '800 mg given three times a day (TID), orally (PO)', 'armGroupLabels': ['Erythropoietin Use', 'Ribavirin Dose Reduction', 'Treated/Not Randomized']}, {'name': 'Peginterferon alfa-2b (PEG2b)', 'type': 'DRUG', 'otherNames': ['SCH 054031'], 'description': '1.5 µg/kg/week given subcutaneously (SC)', 'armGroupLabels': ['Erythropoietin Use', 'Ribavirin Dose Reduction', 'Treated/Not Randomized']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['SCH 018908, Rebetol'], 'description': 'Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO)', 'armGroupLabels': ['Erythropoietin Use', 'Ribavirin Dose Reduction', 'Treated/Not Randomized']}, {'name': 'Erythropoietin', 'type': 'DRUG', 'otherNames': ['Procrit, Eprex'], 'description': 'Initial dose of 40,000 Units given subcutaneously (SC) once weekly (QW), with dose adjustment as necessary to achieve and maintain serum hemoglobin levels of 10-12 g/dL', 'armGroupLabels': ['Erythropoietin Use']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}