Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT00953758
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2009-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of PF-04449913 In Select Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592580', 'term': 'glasdegib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Some participants were administered the lead-in dose at other times (other than Day -6 as stated) due to changes in the timing of the lead-in dose as the protocol was amended a few times.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 8}, {'id': 'EG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gingival hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral mucosal blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tongue haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Crepitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Enterobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary mycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Albumin urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood pressure diastolic decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Clostridium test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymph node palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Monocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Joint crepitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Limb asymmetry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blast cell crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukaemia cutis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Penile blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nail discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blue toe syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonal fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Synovial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 (28 days)', 'description': 'Any DLT event in Cycle 1: 1) Grade \\>=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (\\>) 42 days from the point of detection in a normal bone marrow (less than \\[\\<\\] 500 per microliter \\[/uL\\] or platelet count \\<10,000/uL, or hemoglobin \\<8 gram per deciliter \\[g/dL\\] with \\<5% blasts and no evidence of disease or dysplasia), 3) inability to deliver \\>= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who did not have major treatment deviations in Cycle 1 were evaluable for DLT.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'title': 'Any AEs, Grade 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '40.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '55.6', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 4', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '22.2', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 5', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '40.0', 'groupId': 'OG007'}, {'value': '22.2', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 537 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'title': 'Any AEs, Grade 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '11.1', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '80.0', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 4', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '12.5', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}]}]}, {'title': 'Any AEs, Grade 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 537 days)', 'description': 'An AE was any untoward medical occurrence in a participant. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'title': 'Systolic BP <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Decrease from baseline systolic BP >=30 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Increase from baseline systolic BP >=30 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Diastolic BP <50 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Decrease from baseline diastolic BP >=20 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Increase from baseline diastolic BP >=20 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Heart rate >120 bpm at any time post dose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening up to maximum of 537 days', 'description': 'Participants with systolic blood pressure (BP) less than (\\<) 90 millimeters of mercury (mmHg), maximum increase and decrease from baseline systolic BP of more than or equal to (\\>=) 30 mmHg, diastolic BP \\<50 mmHg, maximum increase and decrease from baseline diastolic BP \\>=20 mmHg, and a heart rate of more than (\\>) 120 beats per minute (bpm) at any time post dose were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening to EOT (maximum duration: 537 days)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality as per the pre defined criteria were reported. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all enrolled participants who received at least 1 dose of PF-04449913, including the lead-in dose.'}, {'type': 'SECONDARY', 'title': 'Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': 'Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system.', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of PF-04449913 and had at least 1 PD parameter in at least 1 treatment period. Results were not collected and reported for the other reporting arms since none of the participants in those arms had evaluable PD samples.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '59.0', 'spread': '21', 'groupId': 'OG001'}, {'value': '247', 'spread': '47', 'groupId': 'OG002'}, {'value': '313', 'spread': '51', 'groupId': 'OG003'}, {'value': '746', 'spread': '56', 'groupId': 'OG004'}, {'value': '1418', 'spread': '22', 'groupId': 'OG005'}, {'value': '1409', 'spread': '79', 'groupId': 'OG006'}, {'value': '1534', 'spread': '72', 'groupId': 'OG007'}, {'value': '3714', 'spread': '30', 'groupId': 'OG008'}, {'value': '4527', 'spread': '64', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '12', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '30', 'groupId': 'OG001'}, {'value': '249', 'spread': '35', 'groupId': 'OG002'}, {'value': '565', 'spread': '83', 'groupId': 'OG003'}, {'value': '871', 'spread': '35', 'groupId': 'OG004'}, {'value': '1621', 'spread': '10', 'groupId': 'OG005'}, {'value': '2069', 'spread': '41', 'groupId': 'OG006'}, {'value': '1504', 'spread': 'NA', 'comment': 'Geometric coefficient of variation (%CV) not reported when there are 2 or less participants.', 'groupId': 'OG007'}, {'value': '4989', 'spread': '7.0', 'groupId': 'OG008'}, {'value': '6413', 'spread': '65', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.1', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '4.1'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '1.3', 'upperLimit': '4.5'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.1', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '0.92', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '2.2', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '6.1'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '3.1', 'groupId': 'OG007', 'lowerLimit': '2.13', 'upperLimit': '4.07'}, {'value': '4.0', 'groupId': 'OG008', 'lowerLimit': '1.1', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG009', 'lowerLimit': '2.2', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.61', 'spread': '19', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '23', 'groupId': 'OG001'}, {'value': '5.63', 'spread': '50', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '37', 'groupId': 'OG003'}, {'value': '9.13', 'spread': '64', 'groupId': 'OG004'}, {'value': '8.33', 'spread': '36', 'groupId': 'OG005'}, {'value': '8.48', 'spread': '64', 'groupId': 'OG006'}, {'value': '10.8', 'spread': '110', 'groupId': 'OG007'}, {'value': '5.90', 'spread': '19', 'groupId': 'OG008'}, {'value': '6.93', 'spread': '58', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'liter (L)/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.57', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '27', 'groupId': 'OG001'}, {'value': '7.79', 'spread': '13', 'groupId': 'OG002'}, {'value': '6.52', 'spread': '62', 'groupId': 'OG003'}, {'value': '10.7', 'spread': '46', 'groupId': 'OG004'}, {'value': '5.33', 'spread': '13', 'groupId': 'OG005'}, {'value': '7.81', 'spread': '48', 'groupId': 'OG006'}, {'value': '11.8', 'spread': 'NA', 'comment': 'As planned, Geometric CV cannot be calculated and reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '5.68', 'spread': '24', 'groupId': 'OG008'}, {'value': '8.36', 'spread': '51', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '262', 'spread': '32', 'groupId': 'OG000'}, {'value': '455', 'spread': '41', 'groupId': 'OG001'}, {'value': '265', 'spread': '62', 'groupId': 'OG002'}, {'value': '367', 'spread': '38', 'groupId': 'OG003'}, {'value': '292', 'spread': '71', 'groupId': 'OG004'}, {'value': '316', 'spread': '52', 'groupId': 'OG005'}, {'value': '210', 'spread': '92', 'groupId': 'OG006'}, {'value': '359', 'spread': '143', 'groupId': 'OG007'}, {'value': '185', 'spread': '50', 'groupId': 'OG008'}, {'value': '191', 'spread': '78', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-life (t1/2) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '34.3', 'spread': '14', 'groupId': 'OG002'}, {'value': '23.3', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '23.3', 'spread': '8.1', 'groupId': 'OG004'}, {'value': '26.5', 'spread': '4.0', 'groupId': 'OG005'}, {'value': '17.4', 'spread': '3.3', 'groupId': 'OG006'}, {'value': '23.6', 'spread': '5.5', 'groupId': 'OG007'}, {'value': '23.9', 'spread': '14', 'groupId': 'OG008'}, {'value': '19.6', 'spread': '4.7', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUCinf) on Lead-in', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '657', 'spread': '19', 'groupId': 'OG000'}, {'value': '786', 'spread': '23', 'groupId': 'OG001'}, {'value': '3548', 'spread': '50', 'groupId': 'OG002'}, {'value': '3614', 'spread': '38', 'groupId': 'OG003'}, {'value': '8755', 'spread': '64', 'groupId': 'OG004'}, {'value': '14430', 'spread': '35', 'groupId': 'OG005'}, {'value': '21280', 'spread': '64', 'groupId': 'OG006'}, {'value': '25110', 'spread': '109', 'groupId': 'OG007'}, {'value': '67720', 'spread': '19', 'groupId': 'OG008'}, {'value': '86620', 'spread': '58', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'unitOfMeasure': 'nanograms*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '583', 'spread': '10', 'groupId': 'OG000'}, {'value': '753', 'spread': '27', 'groupId': 'OG001'}, {'value': '2566', 'spread': '13', 'groupId': 'OG002'}, {'value': '6134', 'spread': '61', 'groupId': 'OG003'}, {'value': '7482', 'spread': '46', 'groupId': 'OG004'}, {'value': '22520', 'spread': '13', 'groupId': 'OG005'}, {'value': '23060', 'spread': '47', 'groupId': 'OG006'}, {'value': '22990', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '70430', 'spread': '24', 'groupId': 'OG008'}, {'value': '71710', 'spread': '51', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Average Plasma Concentration (Cavg) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '27', 'groupId': 'OG001'}, {'value': '107', 'spread': '13', 'groupId': 'OG002'}, {'value': '256', 'spread': '61', 'groupId': 'OG003'}, {'value': '312', 'spread': '46', 'groupId': 'OG004'}, {'value': '940', 'spread': '13', 'groupId': 'OG005'}, {'value': '961', 'spread': '48', 'groupId': 'OG006'}, {'value': '960', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '2933', 'spread': '24', 'groupId': 'OG008'}, {'value': '2986', 'spread': '51', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Minimum Plasma Concentration (Cmin) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '15', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '14', 'groupId': 'OG001'}, {'value': '54.7', 'spread': '46', 'groupId': 'OG002'}, {'value': '162', 'spread': '107', 'groupId': 'OG003'}, {'value': '116', 'spread': '48', 'groupId': 'OG004'}, {'value': '360', 'spread': '115', 'groupId': 'OG005'}, {'value': '408', 'spread': '42', 'groupId': 'OG006'}, {'value': '428', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '1113', 'spread': '44', 'groupId': 'OG008'}, {'value': '1641', 'spread': '59', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentration (Ctrough) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': '17', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '14', 'groupId': 'OG001'}, {'value': '67.8', 'spread': '48', 'groupId': 'OG002'}, {'value': '170', 'spread': '121', 'groupId': 'OG003'}, {'value': '120', 'spread': '53', 'groupId': 'OG004'}, {'value': '495', 'spread': '56', 'groupId': 'OG005'}, {'value': '485', 'spread': '86', 'groupId': 'OG006'}, {'value': '428', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '1291', 'spread': '42', 'groupId': 'OG008'}, {'value': '1871', 'spread': '57', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Cycle 1 Day 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this parameter in this period. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under 180-mg.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.8'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '1.9'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '3.0'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '1.1', 'upperLimit': '2.2'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '1.5', 'upperLimit': '3.4'}, {'value': '1.4', 'groupId': 'OG006', 'lowerLimit': '0.8', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '2.6'}, {'value': '1.2', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '2.8'}, {'value': '1.4', 'groupId': 'OG009', 'lowerLimit': '1.1', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1 hour post-dose on Cycle 1 Day 1; Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21', 'description': 'Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCtau on Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Linearity Ratio (Rss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '0.98'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '1.2'}, {'value': '0.76', 'groupId': 'OG002', 'lowerLimit': '0.71', 'upperLimit': '1.2'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '2.2'}, {'value': '0.97', 'groupId': 'OG004', 'lowerLimit': '0.75', 'upperLimit': '1.7'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '0.91', 'upperLimit': '2.1'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '1.4'}, {'value': '1.0', 'groupId': 'OG007', 'lowerLimit': '0.30', 'upperLimit': '1.77'}, {'value': '0.86', 'groupId': 'OG008', 'lowerLimit': '0.76', 'upperLimit': '2.1'}, {'value': '0.97', 'groupId': 'OG009', 'lowerLimit': '0.72', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose during the lead-in period (Day -6); Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21', 'description': 'Linearity ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCinf after single dose (Lead-in Period \\[Day -6\\]).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = the number of participants analyzed for Cycle 1. 1 participant from the 270-mg arm had dose reduction to 180 mg and is analyzed and reported under the 180-mg arm.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.623', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '42', 'groupId': 'OG001'}, {'value': '0.754', 'spread': '41', 'groupId': 'OG002'}, {'value': '0.385', 'spread': '42', 'groupId': 'OG003'}, {'value': '1.14', 'spread': '79', 'groupId': 'OG004'}, {'value': '0.403', 'spread': '53', 'groupId': 'OG005'}, {'value': '1.27', 'spread': '60', 'groupId': 'OG006'}, {'value': '1.21', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '0.666', 'spread': '27', 'groupId': 'OG008'}, {'value': '1.08', 'spread': '132', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'description': 'Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by the kidneys.', 'unitOfMeasure': 'L/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Amount of Unchanged Drug Excreted in Urine (Over the Dosing Interval) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '352', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG000'}, {'value': '1027', 'spread': '15', 'groupId': 'OG001'}, {'value': '1933', 'spread': '43', 'groupId': 'OG002'}, {'value': '2357', 'spread': '91', 'groupId': 'OG003'}, {'value': '8524', 'spread': '63', 'groupId': 'OG004'}, {'value': '9066', 'spread': '44', 'groupId': 'OG005'}, {'value': '30180', 'spread': '46', 'groupId': 'OG006'}, {'value': '27710', 'spread': 'NA', 'comment': 'Not reported when the number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '44570', 'spread': '38', 'groupId': 'OG008'}, {'value': '77770', 'spread': '85', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'microgram (mcg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Dose Excreted Unchanged in Urine (Over the Dosing Interval) on Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.03', 'spread': 'NA', 'comment': 'Not reported when number of participants is 2 or less.', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '15', 'groupId': 'OG001'}, {'value': '9.68', 'spread': '43', 'groupId': 'OG002'}, {'value': '5.89', 'spread': '91', 'groupId': 'OG003'}, {'value': '10.7', 'spread': '63', 'groupId': 'OG004'}, {'value': '7.57', 'spread': '44', 'groupId': 'OG005'}, {'value': '16.8', 'spread': '46', 'groupId': 'OG006'}, {'value': '10.3', 'spread': 'NA', 'comment': 'Not reported when number of participants is 2 or less.', 'groupId': 'OG007'}, {'value': '11.1', 'spread': '38', 'groupId': 'OG008'}, {'value': '13.0', 'spread': '85', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'unitOfMeasure': 'Percentage of dose', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled and treated (received at least 1 dose of study medication) participants who had at least 1 of the PK parameters of interest. N = number of participants with available data for this PK parameter in this period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS and CMML', 'description': 'Participants with myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG001', 'title': 'Myelofibrosis', 'description': 'Participants with myelofibrosis received oral single agent PF-04449913 tablets once (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) on Day -6 (as a lead-in dose) followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG002', 'title': 'Acute Myeloid Leukemia', 'description': 'Participants with acute myeloid leukemia received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG003', 'title': 'Chronic Myeloid Leukemia (Accelerated Phase/Blast Crisis)', 'description': 'Participants with chronic myeloid leukemia (accelerated phase/blast crisis) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG004', 'title': 'Chronic Myeloid Leukemia (Chronic Phase)', 'description': 'Participants with chronic myeloid leukemia (chronic phase) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '32.1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (up to 537 days)', 'description': 'Percentage of participants with OR based on assessment of disease response according to disease specific response criteria (hematologic, cytogenetic and molecular responses). Results were analyzed based on malignancies, according to the planned analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS and CMML', 'description': 'Participants with myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG001', 'title': 'Myelofibrosis', 'description': 'Participants with myelofibrosis received oral single agent PF-04449913 tablets once (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) on Day -6 (as a lead-in dose) followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG002', 'title': 'Acute Myeloid Leukemia', 'description': 'Participants with acute myeloid leukemia received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG003', 'title': 'Chronic Myeloid Leukemia (Accelerated Phase/Blast Crisis)', 'description': 'Participants with chronic myeloid leukemia (accelerated phase/blast crisis) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG004', 'title': 'Chronic Myeloid Leukemia (Chronic Phase)', 'description': 'Participants with chronic myeloid leukemia (chronic phase) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of 95% confidence interval (CI) was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': 'NA'}, {'value': '10.12', 'comment': 'Upper limit of 95% CI was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': 'NA'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '6.47'}, {'value': '3.75', 'comment': '95% CI was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from start of study treatment to first documentation of objective disease progression or death due to cancer, whichever comes first. TTP was calculated as (first event date - date of first dose of study medication + 1)/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from chronic phase \\[CP\\], progressor to accelerated phase \\[AP\\] or blast crisis \\[BC\\] from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS and CMML', 'description': 'Participants with myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG001', 'title': 'Myelofibrosis', 'description': 'Participants with myelofibrosis received oral single agent PF-04449913 tablets once (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) on Day -6 (as a lead-in dose) followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG002', 'title': 'Acute Myeloid Leukemia', 'description': 'Participants with acute myeloid leukemia received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG003', 'title': 'Chronic Myeloid Leukemia (Accelerated Phase/Blast Crisis)', 'description': 'Participants with chronic myeloid leukemia (accelerated phase/blast crisis) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG004', 'title': 'Chronic Myeloid Leukemia (Chronic Phase)', 'description': 'Participants with chronic phase chronic myeloid leukemia received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.45', 'comment': '95% CI was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG001', 'lowerLimit': '3.71', 'upperLimit': 'NA'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '3.75'}, {'value': 'NA', 'comment': 'Median and 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from the first documentation of objective response to objective disease progression or death due to any cancer. DR was calculated as \\[date of first documentation of progression or death due to cancer - date of first disease response + 1\\]/30.4. DR was calculated for the subgroup of participants with an objective disease response.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS and CMML', 'description': 'Participants with myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG001', 'title': 'Myelofibrosis', 'description': 'Participants with myelofibrosis received oral single agent PF-04449913 tablets once (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) on Day -6 (as a lead-in dose) followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG002', 'title': 'Acute Myeloid Leukemia', 'description': 'Participants with acute myeloid leukemia received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG003', 'title': 'Chronic Myeloid Leukemia (Accelerated Phase/Blast Crisis)', 'description': 'Participants with chronic myeloid leukemia (accelerated phase/blast crisis) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}, {'id': 'OG004', 'title': 'Chronic Myeloid Leukemia (Chronic Phase)', 'description': 'Participants with chronic myeloid leukemia (chronic phase) received oral single agent PF-04449913 tablets (5, 10, 20, 40, 80, 120, 180, 270, 400 or 600 mg) once on Day -6 (as a lead-in dose), followed by QD dosing starting on Cycle 1 Day 1, without interruption, in 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': 'NA'}, {'value': '4.43', 'comment': 'Upper limit of 95% CI was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': 'NA'}, {'value': '2.83', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '3.75'}, {'value': '3.75', 'comment': '95% CI was not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI were not achieved/estimable due to the limited number of participants with events in the study.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from start of study treatment to first documentation of objective disease progression or death due to any cause. PFS was calculated as \\[first event date - date of first dose of study medication + 1\\]/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from CP, progressor to AP or BC from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response; or from adverse event data (where the outcome was "Death").', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Set consisted of all enrolled participants who received Cycle 1 Day 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Increase From Baseline in Corrected QT Interval Using Fridericia's Formula (QTcF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'title': 'QTcF, maximum increase from baseline: <30 msec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QTcF, maximum increase from baseline: 30-<60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QTcF, maximum increase from baseline: >=60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening; predose, 1, 4, 24 hours (hr) postdose on Day -6; predose, 1 hr postdose on Cycle 1 Day 1; 1 hr postdose on Cycle 1 Days 8, 15; Day 1 of every subsequent cycle; predose, 1, 2, 4, 24 hr postdose for Cycle 1 Day 21; EOT (max reached: Cycle 20)', 'description': "Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. The time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of \\<30 millisecond (msec), 30 to \\<60 msec and \\>=60 msec were summarized.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Decrease From Baseline in QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'title': 'QTcF, maximum decrease from baseline: <30 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}]}, {'title': 'QTcF, maximum decrease from baseline: 30-<60 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QTcF, maximum decrease from baseline: >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to maximum of 537 days', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of \\<30 msec, 30 to \\<60 msec and \\>=60 msec were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline QTcF Interval >= 500 Msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'OG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to maximum of 537 days', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with post-baseline absolute QTcF values \\>=500 msec were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of PF-04449913.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'FG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Participant refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Participant went for transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '47', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04449913 5 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 5 milligram (mg) once on Day -6 (as a lead-in dose), followed by once daily (QD) dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG001', 'title': 'PF-04449913 10 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 10 mg once on Day -6 (as a lead-in dose), followed by QD dosing from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG002', 'title': 'PF-04449913 20 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 20 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG003', 'title': 'PF-04449913 40 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 40 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG004', 'title': 'PF-04449913 80 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 80 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG005', 'title': 'PF-04449913 120 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 120 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG006', 'title': 'PF-04449913 180 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 180 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG007', 'title': 'PF-04449913 270 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 270 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG008', 'title': 'PF-04449913 400 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 400 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG009', 'title': 'PF-04449913 600 mg', 'description': 'Participants received oral single agent PF-04449913 tablets 600 mg once on Day -6 (as a lead-in dose), followed by QD dosing starting from Cycle 1 Day 1, without interruption, in 28-day cycles (maximum duration: 537 days).'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '32', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '28', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2013-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2009-08-04', 'resultsFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-21', 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 Day 1 to end of Cycle 1 (28 days)', 'description': 'Any DLT event in Cycle 1: 1) Grade \\>=3 non-hematologic toxicity that had been maximally treated, 2) prolonged myelosupression that lasted greater than (\\>) 42 days from the point of detection in a normal bone marrow (less than \\[\\<\\] 500 per microliter \\[/uL\\] or platelet count \\<10,000/uL, or hemoglobin \\<8 gram per deciliter \\[g/dL\\] with \\<5% blasts and no evidence of disease or dysplasia), 3) inability to deliver \\>= 80% of the planned doses due to PF-04449913 related non-hematologic and hematologic toxicities'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (AEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 3.0) Grade', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 537 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported.'}, {'measure': 'Percentage of Participants With Treatment-related Adverse Events (AEs), by NCI CTCAE Version 3.0) Grade', 'timeFrame': 'Baseline up to 28 days post last dose of study medication (maximum duration: 537 days)', 'description': 'An AE was any untoward medical occurrence in a participant. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade (1 = mild AE, 2 = moderate AE, 3 = severe AE, 4 = life-threatening or disabling AE, 5 = death related to AE) was reported.'}, {'measure': 'Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria', 'timeFrame': 'Screening up to maximum of 537 days', 'description': 'Participants with systolic blood pressure (BP) less than (\\<) 90 millimeters of mercury (mmHg), maximum increase and decrease from baseline systolic BP of more than or equal to (\\>=) 30 mmHg, diastolic BP \\<50 mmHg, maximum increase and decrease from baseline diastolic BP \\>=20 mmHg, and a heart rate of more than (\\>) 120 beats per minute (bpm) at any time post dose were summarized.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Screening to EOT (maximum duration: 537 days)', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality as per the pre defined criteria were reported. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).'}, {'measure': 'Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression to Baseline for Normal Skin on Cycle 1 Day 21', 'timeFrame': 'Baseline, Cycle 1 Day 21', 'description': 'Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Apparent Oral Clearance (CL/F) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Apparent Oral Clearance (CL/F) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Plasma Decay Half-life (t1/2) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUCinf) on Lead-in', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96 and 120 hours post-dose during the lead-in period (Day -6)'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Average Plasma Concentration (Cavg) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Minimum Plasma Concentration (Cmin) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Pre-dose Concentration (Ctrough) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose on Cycle 1 Day 21'}, {'measure': 'Accumulation Ratio (Rac)', 'timeFrame': 'Pre-dose, 1 hour post-dose on Cycle 1 Day 1; Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21', 'description': 'Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCtau on Cycle 1 Day 1.'}, {'measure': 'Linearity Ratio (Rss)', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose during the lead-in period (Day -6); Pre-dose, 0.5, 1, 2, 4, 8 and 24 hours post-dose on Cycle 1 Day 21', 'description': 'Linearity ratio was calculated as AUCtau at steady state (Cycle 1/Day 21)/AUCinf after single dose (Lead-in Period \\[Day -6\\]).'}, {'measure': 'Renal Clearance on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21', 'description': 'Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by the kidneys.'}, {'measure': 'Amount of Unchanged Drug Excreted in Urine (Over the Dosing Interval) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Percentage of Dose Excreted Unchanged in Urine (Over the Dosing Interval) on Cycle 1 Day 21', 'timeFrame': 'Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on Cycle 1 Day 21'}, {'measure': 'Percentage of Participants With Objective Response (OR)', 'timeFrame': 'Baseline to end of study (up to 537 days)', 'description': 'Percentage of participants with OR based on assessment of disease response according to disease specific response criteria (hematologic, cytogenetic and molecular responses). Results were analyzed based on malignancies, according to the planned analysis.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from start of study treatment to first documentation of objective disease progression or death due to cancer, whichever comes first. TTP was calculated as (first event date - date of first dose of study medication + 1)/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from chronic phase \\[CP\\], progressor to accelerated phase \\[AP\\] or blast crisis \\[BC\\] from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response).'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from the first documentation of objective response to objective disease progression or death due to any cancer. DR was calculated as \\[date of first documentation of progression or death due to cancer - date of first disease response + 1\\]/30.4. DR was calculated for the subgroup of participants with an objective disease response.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline to end of study, up to 36 months', 'description': 'Time in months from start of study treatment to first documentation of objective disease progression or death due to any cause. PFS was calculated as \\[first event date - date of first dose of study medication + 1\\]/30.4. Disease progression was determined from oncologic assessment data (where data met the criteria for disease progression: categorized as early progressor from CP, progressor to AP or BC from CP or return to CP, progressor to AP to BC, loss of confirmed complete hematologic response, or loss of major cytogenetic response; or from adverse event data (where the outcome was "Death").'}, {'measure': "Number of Participants With Increase From Baseline in Corrected QT Interval Using Fridericia's Formula (QTcF)", 'timeFrame': 'Screening; predose, 1, 4, 24 hours (hr) postdose on Day -6; predose, 1 hr postdose on Cycle 1 Day 1; 1 hr postdose on Cycle 1 Days 8, 15; Day 1 of every subsequent cycle; predose, 1, 2, 4, 24 hr postdose for Cycle 1 Day 21; EOT (max reached: Cycle 20)', 'description': "Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. The time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of \\<30 millisecond (msec), 30 to \\<60 msec and \\>=60 msec were summarized."}, {'measure': 'Number of Participants With Decrease From Baseline in QTcF Interval', 'timeFrame': 'Baseline up to maximum of 537 days', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of \\<30 msec, 30 to \\<60 msec and \\>=60 msec were summarized.'}, {'measure': 'Number of Participants With Post-baseline QTcF Interval >= 500 Msec', 'timeFrame': 'Baseline up to maximum of 537 days', 'description': 'Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and the average was calculated. QTcF was calculated. Participants with post-baseline absolute QTcF values \\>=500 msec were summarized.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor'], 'conditions': ['Hematologic Malignancies']}, 'referencesModule': {'references': [{'pmid': '33993815', 'type': 'DERIVED', 'citation': 'Fostvedt LK, Shaik N, Martinelli G, Wagner AJ, Ruiz-Garcia A. Exposure-response modeling of the effect of glasdegib on cardiac repolarization in patients with cancer. Expert Rev Clin Pharmacol. 2021 Jul;14(7):927-935. doi: 10.1080/17512433.2021.1925538. Epub 2021 May 18.'}, {'pmid': '26688487', 'type': 'DERIVED', 'citation': "Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015 Aug;2(8):e339-46. doi: 10.1016/S2352-3026(15)00096-4. Epub 2015 Jul 26."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371001&StudyName=A%20Study%20Of%20PF-04449913%20In%20Select%20Hematologic%20Malignancies', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response.\n* ECOG performance status 0 to 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Patients with active CNS disease\n* Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer\n* Active GVHD other than Grade 1 skin involvement\n* Known malabsorption syndrome\n* Patient has an active, life threatening or clinically significant uncontrolled systemic infection'}, 'identificationModule': {'nctId': 'NCT00953758', 'briefTitle': 'A Study Of PF-04449913 In Select Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS SINGLE AGENT IN SELECT HEMATOLOGIC MALIGNANCIES', 'orgStudyIdInfo': {'id': 'B1371001'}, 'secondaryIdInfos': [{'id': '2009-011285-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PF-04449913']}], 'interventions': [{'name': 'PF-04449913', 'type': 'DRUG', 'description': 'Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center - La Jolla', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center - Hillcrest', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109-1023', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center, Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'U.O. di Ematologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}