Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3.', 'description': 'Local reactions and systemic events were collected by the participants using an electronic diary checklist (systematic assessment). AE/SAEs were documented by investigator on the case report form (non-systematic assessment) at each visit.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC: Visit 1 to Visit 2', 'description': 'Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.', 'otherNumAtRisk': 1049, 'otherNumAffected': 486, 'seriousNumAtRisk': 1049, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': '13vPnC: 6-month Follow-up', 'description': 'Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.', 'otherNumAtRisk': 1049, 'otherNumAffected': 77, 'seriousNumAtRisk': 1049, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Redness (any)', 'notes': 'Redness (any) = present at site of vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 666, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (mild)', 'notes': 'Redness (mild) = 2.5 to 5.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 660, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (moderate)', 'notes': 'Redness (moderate) = 5.1 to 10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 649, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Redness (severe)', 'notes': 'Redness (severe) = \\>10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 638, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (any)', 'notes': 'Swelling (any) = present at site of vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 664, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (mild)', 'notes': 'Swelling (mild) = 2.5 to 5.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (moderate)', 'notes': 'Swelling (moderate) = 5.1 to 10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Swelling (severe)', 'notes': 'Swelling (severe) = 10.0 cm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (any)', 'notes': 'Pain (any) = present at site of vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 777, 'numAffected': 396}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (mild)', 'notes': 'Pain (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 770, 'numAffected': 380}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (moderate)', 'notes': 'Pain (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Pain (severe)', 'notes': 'Pain (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (any)', 'notes': 'Limitation of arm movement (any) = present due to vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (mild)', 'notes': 'Limitation of arm movement (mild) = some limitation of arm movement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 674, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (moderate)', 'notes': 'Limitation of arm movement (moderate) = unable to move arm above head but able to move arm above shoulder.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Limitation of arm movement (severe)', 'notes': 'Limitation of arm movement (severe) = unable to move arm above shoulder.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 640, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local reactions'}, {'term': 'Fever (any)', 'notes': 'Fever (any) = ≥38 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 641, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (mild)', 'notes': 'Fever (mild) = ≥38 degrees C but \\<38.5 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (moderate)', 'notes': 'Fever (moderate) = ≥38.5 degrees C but \\<39 degrees C.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (severe)', 'notes': 'Fever (severe) = ≥39 degrees C but ≤40 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fever (potentially life threatening)', 'notes': 'Fever (potentially life threatening) = \\>40 degrees C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 638, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fatigue (any)', 'notes': 'Fatigue (any) = fatigue present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 733, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fatigue (mild)', 'notes': 'Fatigue (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 204}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fatigue (moderate)', 'notes': 'Fatigue (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 683, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Fatigue (severe)', 'notes': 'Fatigue (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Headache (any)', 'notes': 'Headache (any) = headache present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 702, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Headache (mild)', 'notes': 'Headache (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 696, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Headache (moderate)', 'notes': 'Headache (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Headache (severe)', 'notes': 'Headache (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 637, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Vomiting (any)', 'notes': 'Vomiting (any) = vomiting present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 638, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Vomiting (mild)', 'notes': 'Vomiting (mild) = no interference with activity or 1 to 2 times in 24 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 637, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Vomiting (moderate)', 'notes': 'Vomiting (moderate) = some interference with activity or more than 2 times in 24 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Vomiting (severe)', 'notes': 'Vomiting (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 634, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 668, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Diarrhea (any)', 'notes': 'Diarrhea (any) = diarrhea present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 684, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Diarrhea (mild)', 'notes': 'Diarrhea (mild) = 2 to 3 loose stools in 24 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 678, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Diarrhea (moderate)', 'notes': 'Diarrhea (moderate) = 4 to 5 loose stools in 24 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 644, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Diarrhea (severe)', 'notes': 'Diarrhea (severe) = 6 or more loose stools in 24 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 635, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized muscle pain (any)', 'notes': 'New generalized muscle pain (any) = new generalized muscle pain present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 700, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized muscle pain (mild)', 'notes': 'New generalized muscle pain (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 679, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized muscle pain (moderate)', 'notes': 'New generalized muscle pain (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 658, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized muscle pain (severe)', 'notes': 'New generalized muscle pain (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 636, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized muscle pain (any)', 'notes': 'Aggravated generalized muscle pain (any) = aggravated generalized muscle pain present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized muscle pain (mild)', 'notes': 'Aggravated generalized muscle pain (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 650, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized muscle pain (moderate)', 'notes': 'Aggravated generalized muscle pain (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized muscle pain (severe)', 'notes': 'Aggravated generalized muscle pain (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized joint pain (any)', 'notes': 'New generalized joint pain (any) = new generalized joint pain present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized joint pain (mild)', 'notes': 'New generalized joint pain (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 651, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized joint pain (moderate)', 'notes': 'New generalized joint pain (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 648, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'New generalized joint pain (severe)', 'notes': 'New generalized joint pain (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 637, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized joint pain (any)', 'notes': 'Aggravated generalized joint pain (any) = aggravated generalized joint pain present.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized joint pain (mild)', 'notes': 'Aggravated generalized joint pain (mild) = no interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 647, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized joint pain (moderate)', 'notes': 'Aggravated generalized joint pain (moderate) = some interference with activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 647, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Aggravated generalized joint pain (severe)', 'notes': 'Aggravated generalized joint pain (severe) = prevents routine daily activity.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 637, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic events'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Postoperative renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1049, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Pre-specified Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.'}], 'classes': [{'title': 'Redness: Any (n=666)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '17.2'}]}]}, {'title': 'Redness: Mild (n=660)', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '15.3'}]}]}, {'title': 'Redness: Moderate (n=649)', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '8.6'}]}]}, {'title': 'Redness: Severe (n=638)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Any (n=664)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '15.6'}]}]}, {'title': 'Swelling: Mild (n=658)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '13.6'}]}]}, {'title': 'Swelling: Moderate (n=651)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '7.6'}]}]}, {'title': 'Swelling: Severe (n=636)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}, {'title': 'Pain: Any (n=777)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '54.5'}]}]}, {'title': 'Pain: Mild (n=770)', 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '52.9'}]}]}, {'title': 'Pain: Moderate (n=656)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '11.4'}]}]}, {'title': 'Pain: Severe (n=634)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'Limitation of arm movement: Any (n=679)', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '19.2'}]}]}, {'title': 'Limitation of arm movement: Mild (n=674)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '17.7'}]}]}, {'title': 'Limitation of arm movement: Moderate (n=636)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.9'}]}]}, {'title': 'Limitation of arm movement: Severe (n=640)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.9'}]}]}, {'title': 'Any local reaction (n=802)', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '53.1', 'upperLimit': '60.1'}]}]}, {'title': 'Any severe local reaction (n=643)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14', 'description': 'Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\\[cm\\]); moderate(5.1-10.0 cm); severe(\\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting "yes" for at least 1 day or "no" for all days.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Pre-specified Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.'}], 'classes': [{'title': 'Fever (any): >=38 degrees C (n=641)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '3.4'}]}]}, {'title': 'Fever: >=38 degrees C but <38.5 degrees C (n=636)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}, {'title': 'Fever: >=38.5 degrees C but <39 degrees C (n=634)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}, {'title': 'Fever: >=39 degrees C but <=40 degrees C (n=635)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: >40 degrees C (n=638)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}]}]}, {'title': 'Fatigue: Any (n=733)', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '37.9'}]}]}, {'title': 'Fatigue: Mild (n=710)', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '32.2'}]}]}, {'title': 'Fatigue: Moderate (n=683)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '18.1'}]}]}, {'title': 'Fatigue: Severe (n=639)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '3.5'}]}]}, {'title': 'Headache: Any (n=702)', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '29.5'}]}]}, {'title': 'Headache: Mild (n=696)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '27.5'}]}]}, {'title': 'Headache: Moderate (n=655)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '11.5'}]}]}, {'title': 'Headache: Severe (n=637)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}, {'title': 'Chills (n=651)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '9.8'}]}]}, {'title': 'Rash (n=658)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '10.7'}]}]}, {'title': 'Vomiting: Any (vomiting present; n=638)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}]}]}, {'title': 'Vomiting: Mild (1 to 2 times in 24 hours;n=637)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}, {'title': 'Vomiting: Moderate (>2 times in 24 hours;n=635)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'Vomiting: Severe (prevents routine activity;n=634)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}, {'title': 'Decreased appetite (n=668)', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '13.9'}]}]}, {'title': 'Diarrhea: Any (diarrhea present; n=684)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '17.3'}]}]}, {'title': 'Diarrhea: Mild (2 to 3 loose stools/day; n=678)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '15.6'}]}]}, {'title': 'Diarrhea: Moderate (4 to 5 loose stools/day;n=644)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '5.1'}]}]}, {'title': 'Diarrhea: Severe (>=6 loose stools/day; n=635)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'New generalized muscle pain: Any (n=700)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '28.7'}]}]}, {'title': 'New generalized muscle pain: Mild (n=679)', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '23.7'}]}]}, {'title': 'New generalized muscle pain: Moderate (n=658)', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '10.2'}]}]}, {'title': 'New generalized muscle pain: Severe (n=636)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.6'}]}]}, {'title': 'Aggravated generalized muscle pain: Any (n=669)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '15.0'}]}]}, {'title': 'Aggravated generalized muscle pain: Mild (n=650)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '9.8'}]}]}, {'title': 'Aggravated generalized muscle pain:Moderate(n=655)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '8.6'}]}]}, {'title': 'Aggravated generalized muscle pain: Severe (n=639)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.7'}]}]}, {'title': 'New generalized joint pain: Any (n=665)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '15.6'}]}]}, {'title': 'New generalized joint pain: Mild (n=651)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '10.5'}]}]}, {'title': 'New generalized joint pain: Moderate (n=648)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.8'}]}]}, {'title': 'New generalized joint pain: Severe (n=637)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.8'}]}]}, {'title': 'Aggravated generalized joint pain: Any (n=661)', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '12.2'}]}]}, {'title': 'Aggravated generalized joint pain: Mild (n=647)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.8'}]}]}, {'title': 'Aggravated generalized joint pain: Moderate(n=647)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '7.1'}]}]}, {'title': 'Aggravated generalized joint pain: Severe (n=637)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.3'}]}]}, {'title': 'Any systemic event (n=832)', 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '61.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14', 'description': 'Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\\>=38 degrees Celsius\\[C\\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\\>2 times daily; severe:prevents daily activity) decreased appetite \\& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\\>=6 loose stools/day) reported. Participants may be represented in \\>1 category.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Taking Pain or Antipyretic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.'}], 'classes': [{'title': 'Use of medication to treat pain (n=677)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '20.0'}]}]}, {'title': 'Use of medication to treat fever (n=655)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '8.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 through 14', 'description': 'Use of pain or antipyretic medication was collected by the participants using an electronic diary.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1053'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1049'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1040'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Assigned, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '584', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '465', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1053}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'dispFirstSubmitDate': '2010-03-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-11', 'studyFirstSubmitDate': '2007-07-09', 'dispFirstSubmitQcDate': '2010-03-02', 'resultsFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2007-07-10', 'dispFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-11', 'studyFirstPostDateStruct': {'date': '2007-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Pre-specified Local Reactions', 'timeFrame': 'Days 1 through 14', 'description': 'Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\\[cm\\]); moderate(5.1-10.0 cm); severe(\\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants With Pre-specified Systemic Events', 'timeFrame': 'Days 1 through 14', 'description': 'Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\\>=38 degrees Celsius\\[C\\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\\>2 times daily; severe:prevents daily activity) decreased appetite \\& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\\>=6 loose stools/day) reported. Participants may be represented in \\>1 category.'}, {'measure': 'Percentage of Participants Taking Pain or Antipyretic Medication', 'timeFrame': 'Days 1 through 14', 'description': 'Use of pain or antipyretic medication was collected by the participants using an electronic diary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumococcal conjugate vaccine', 'vaccine'], 'conditions': ['Pneumococcal Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '68 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "MAIN INCLUSION CRITERIA:\n\n* Male or female aged 68 years or older\n* Determined by medical history, physical examination, and clinical judgment to be eligible for the study\n* Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment\n\nMAIN EXCLUSION CRITERIA:\n\n* Known history of severe reaction to a vaccine\n* Documented S pneumoniae infection within the past 5 years.\n* Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids\n* Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study."}, 'identificationModule': {'nctId': 'NCT00500266', 'briefTitle': 'Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment', 'orgStudyIdInfo': {'id': '6115A1-3000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '13-valent Pneumococcal Conjugate Vaccine', 'interventionNames': ['Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)']}], 'interventions': [{'name': '13-valent Pneumococcal Conjugate Vaccine (13vPnC)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85104', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '32703', 'city': 'Apopka', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.67617, 'lon': -81.51186}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32626', 'city': 'Chiefland', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.47496, 'lon': -82.85984}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '32935', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '67005', 'city': 'Arkansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.06197, 'lon': -97.03837}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 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