Viewing Study NCT01250756

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 11:18 PM
Ignite Modification Date: 2025-12-31 @ 11:44 AM
Study NCT ID: NCT01250756
Status: COMPLETED
Last Update Posted: 2013-02-26
First Post: 2010-11-29
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}]}}, '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': 'AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).', 'description': 'Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': '7vPnC + DTaP - Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.', 'otherNumAtRisk': 159, 'otherNumAffected': 123, 'seriousNumAtRisk': 159, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'DTaP (Catch-up 7vPnC)- Infant Series', 'description': 'Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.', 'otherNumAtRisk': 158, 'otherNumAffected': 126, 'seriousNumAtRisk': 158, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': '7vPnC + DTaP - After the Infant Series', 'description': 'Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.', 'otherNumAtRisk': 159, 'otherNumAffected': 20, 'seriousNumAtRisk': 159, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'DTaP (Catch-up 7vPnC) - After the Infant Series', 'description': 'Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.', 'otherNumAtRisk': 158, 'otherNumAffected': 129, 'seriousNumAtRisk': 158, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': '7vPnC + DTaP - Toddler Dose', 'description': 'Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.', 'otherNumAtRisk': 122, 'otherNumAffected': 72, 'seriousNumAtRisk': 122, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DTaP (Catch-up 7vPnC) - Toddler Dose', 'description': 'Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.', 'otherNumAtRisk': 149, 'otherNumAffected': 96, 'seriousNumAtRisk': 149, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'DTaP (Catch-up 7vPnC) - After the Toddler Dose', 'description': 'Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.', 'otherNumAtRisk': 149, 'otherNumAffected': 85, 'seriousNumAtRisk': 149, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaccination site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaccination site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaccination site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Milk allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 43}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory syncytial virus bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Genital candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mucocutaneous candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Staphylococcal scalded skin syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaccination site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lactose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema infantile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asteatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infantile asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis perennial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Allergy to animal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalised erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Genital rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 72}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 56}, {'groupId': 'EG005', 'numAtRisk': 137, 'numAffected': 44}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 73}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Any)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 134, 'numAffected': 43}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 51}, {'groupId': 'EG005', 'numAtRisk': 137, 'numAffected': 39}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 65}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Mild)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 133, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Moderate)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Erythema (Severe)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 137, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Any)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 134, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 44}, {'groupId': 'EG005', 'numAtRisk': 137, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Mild)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 144, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 133, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Moderate)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Induration (Severe)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Any)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Any)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Any)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Tenderness (Significant)', 'notes': 'Infant Series Dose 3 / After Toddler Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Fever ≥37.5°C but ≤39°C', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 103, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 135, 'numAffected': 30}, {'groupId': 'EG006', 'numAtRisk': 134, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever ≥37.5°C but ≤39°C', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 138, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever ≥37.5°C but ≤39°C', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever>39°C but ≤40°C', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever>39°C but ≤40°C', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever>39°C but ≤40°C', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever >40.0°C', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever >40.0°C', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever >40.0°C', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased appetite', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased appetite', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased appetite', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Irritability', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Irritability', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Irritability', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 139, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Increased sleep', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 103, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 135, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Increased sleep', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Increased sleep', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased sleep', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 101, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased sleep', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Decreased sleep', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Hives (urticaria)', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 135, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Hives (urticaria)', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Hives (urticaria)', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Use of antipyretic medication to treat symptoms', 'notes': 'Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 133, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 130, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Use of antipyretic medication to treat symptoms', 'notes': 'Infant Series Dose 2 / After Infant Series Dose 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Use of antipyretic medication to treat symptoms', 'notes': 'Infant Series Dose 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 138, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}], 'seriousEvents': [{'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory syncytial virus bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight gain poor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Infantile asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '1.49'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.91', 'upperLimit': '1.09'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.16'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '76.79', 'groupId': 'OG000', 'lowerLimit': '70.81', 'upperLimit': '83.28'}, {'value': '83.56', 'groupId': 'OG001', 'lowerLimit': '77.54', 'upperLimit': '90.05'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '72.89', 'groupId': 'OG000', 'lowerLimit': '65.80', 'upperLimit': '80.74'}, {'value': '77.85', 'groupId': 'OG001', 'lowerLimit': '71.01', 'upperLimit': '85.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '100.0'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '100.0'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '99.5'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '94.6', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '11.82', 'groupId': 'OG000', 'lowerLimit': '10.50', 'upperLimit': '13.31'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '4.23', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '4.97'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '5.96', 'groupId': 'OG000', 'lowerLimit': '5.37', 'upperLimit': '6.62'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '16.61', 'groupId': 'OG000', 'lowerLimit': '14.66', 'upperLimit': '18.81'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '5.48', 'groupId': 'OG000', 'lowerLimit': '4.76', 'upperLimit': '6.31'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '8.85', 'groupId': 'OG000', 'lowerLimit': '7.54', 'upperLimit': '10.40'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000', 'lowerLimit': '3.54', 'upperLimit': '4.91'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series', 'description': 'Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': 'Pertussis toxoid (PT)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': 'Filamentous hemagglutinin (FHA)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Diphtheria', 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.35', 'upperLimit': '2.78'}, {'value': '2.14', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '2.35'}]}]}, {'title': 'Tetanus', 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.26', 'upperLimit': '2.82'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '2.74', 'upperLimit': '3.38'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'PT', 'categories': [{'measurements': [{'value': '106.54', 'groupId': 'OG000', 'lowerLimit': '96.10', 'upperLimit': '118.12'}, {'value': '130.62', 'groupId': 'OG001', 'lowerLimit': '119.60', 'upperLimit': '142.65'}]}]}, {'title': 'FHA', 'categories': [{'measurements': [{'value': '120.99', 'groupId': 'OG000', 'lowerLimit': '109.75', 'upperLimit': '133.39'}, {'value': '145.38', 'groupId': 'OG001', 'lowerLimit': '132.41', 'upperLimit': '159.63'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '12.15', 'groupId': 'OG000', 'lowerLimit': '10.35', 'upperLimit': '14.26'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '10.66', 'groupId': 'OG000', 'lowerLimit': '8.96', 'upperLimit': '12.68'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '6.43', 'groupId': 'OG000', 'lowerLimit': '5.57', 'upperLimit': '7.42'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '15.83', 'groupId': 'OG000', 'lowerLimit': '13.81', 'upperLimit': '18.14'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '6.53', 'groupId': 'OG000', 'lowerLimit': '5.49', 'upperLimit': '7.76'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '9.70', 'groupId': 'OG000', 'lowerLimit': '8.15', 'upperLimit': '11.56'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '10.17', 'groupId': 'OG000', 'lowerLimit': '8.58', 'upperLimit': '12.07'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the toddler dose', 'description': 'Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '6.74', 'groupId': 'OG000', 'lowerLimit': '5.75', 'upperLimit': '7.90'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '5.89', 'groupId': 'OG000', 'lowerLimit': '5.09', 'upperLimit': '6.81'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '4.34', 'groupId': 'OG000', 'lowerLimit': '3.81', 'upperLimit': '4.93'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '3.63', 'groupId': 'OG000', 'lowerLimit': '3.22', 'upperLimit': '4.09'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '6.90', 'groupId': 'OG000', 'lowerLimit': '6.06', 'upperLimit': '7.85'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '6.37', 'groupId': 'OG000', 'lowerLimit': '5.35', 'upperLimit': '7.59'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '8.10', 'groupId': 'OG000', 'lowerLimit': '7.01', 'upperLimit': '9.35'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-toddler dose, 1 month after the toddler dose', 'description': 'Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.', 'unitOfMeasure': 'Fold Rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the catch-up dose 3', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': '4', 'categories': [{'measurements': [{'value': '6.63', 'groupId': 'OG000', 'lowerLimit': '5.91', 'upperLimit': '7.44'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '4.30', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '4.93'}]}]}, {'title': '9V', 'categories': [{'measurements': [{'value': '3.48', 'groupId': 'OG000', 'lowerLimit': '3.12', 'upperLimit': '3.89'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '11.55', 'groupId': 'OG000', 'lowerLimit': '10.30', 'upperLimit': '12.95'}]}]}, {'title': '18C', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '3.57'}]}]}, {'title': '19F', 'categories': [{'measurements': [{'value': '5.16', 'groupId': 'OG000', 'lowerLimit': '4.45', 'upperLimit': '5.99'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '4.41', 'groupId': 'OG000', 'lowerLimit': '3.78', 'upperLimit': '5.14'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the catch-up dose 3', 'description': 'Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 152, 152)', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Mild (n= 152, 151)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Moderate (n= 148, 152)', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Severe (n= 148, 151)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Any (n= 149, 153)', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Mild (n= 149, 153)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Moderate (n= 148, 151)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Severe (n= 148, 151)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Any (n= 148, 151)', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Significant (n= 148, 151)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Any local reaction (n= 152, 154)', 'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 142, 150)', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Mild (n= 142, 150)', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Moderate (n= 134, 147)', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Severe (n= 133, 147)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Any (n= 137, 150)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Mild (n= 137, 150)', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Moderate (n= 134, 148)', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Severe (n= 133, 147)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Any (n= 133, 147)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Significant (n= 133, 147)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Any local reaction (n= 143, 151)', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 123, 144)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Mild (n= 123, 143)', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Moderate (n= 120, 139)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Severe (n= 118, 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Any (n= 124, 144)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Mild (n= 124, 144)', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Moderate (n= 119, 139)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Severe (n= 118, 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Any (n= 119, 138)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Significant (n= 118, 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Any local reaction (n= 126, 145)', 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 108, 137)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Mild (n= 106, 137)', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Moderate (n= 102, 134)', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Erythema-Severe (n= 98, 133)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Any (n= 108, 137)', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Mild (n= 108, 137)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Moderate (n= 99, 133)', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Induration-Severe (n= 98, 133)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Any (n= 99, 136)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness-Significant (n= 98, 133)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Any local reaction (n= 110, 138)', 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 139)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Mild (n= 139)', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Moderate (n= 136)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Severe (n= 135)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Any (n= 138)', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Mild (n= 138)', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Moderate (n= 135)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Severe (n= 135)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Any (n= 136)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Significant (n= 135)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Any local reaction (n= 141)', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 1', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 144)', 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Mild (n= 144)', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Moderate (n= 140)', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Severe (n= 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Any (n= 144)', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Mild (n= 143)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Moderate (n= 140)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Severe (n= 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Any (n= 139)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Significant (n= 138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Any local reaction (n= 145)', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 2', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Erythema-Any (n= 134)', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Mild (n= 133)', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Moderate (n= 131)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Erythema-Severe (n= 130)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Any (n= 134)', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Mild (n= 133)', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Moderate (n= 131)', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Induration-Severe (n= 130)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Any (n= 132)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Tenderness-Significant (n= 130)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Any local reaction (n= 137)', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 3', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=149,152)', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=148,151)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C(n=148,151)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite(n=148,151)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Irritability(n=151,151)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep(n=150,153)', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep(n=151,151)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'Hives (urticaria)(n=148,151)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=148,151)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Any systemic event(n=154,153)', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '48.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=138,149)', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=135,147)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C(n=133,147)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite(n=135,147)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Irritability(n=134,149)', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep(n=136,148)', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep(n=140,151)', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'Hives (urticaria)(n=133,147)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=134,147)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Any systemic event(n=142,153)', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}, {'value': '38.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=120,141)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=118,138)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C(n=118,138)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite(n=119,138)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Irritability(n=118,139)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep(n=119,141)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep(n=120,140)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Hives (urticaria)(n=119,138)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=119,138)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Any systemic event(n=122,143)', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'OG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=103,135)', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=99,132)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever >40 degrees C(n=98,132)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite(n=100,133)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Irritability(n=100,134)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep(n=103,135)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep(n=101,133)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Hives (urticaria)(n=98,133)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=98,133)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Any systemic event(n=108,138)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '39.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=139)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=135)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Fever >40 degrees C(n=135)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Decreased appetite(n=136)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Irritability(n=136)', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Increased sleep(n=136)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'Decreased sleep(n=136)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Hives (urticaria)(n=135)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=136)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Any systemic event(n=139)', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 1', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=140)', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=138)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Fever >40 degrees C(n=138)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Decreased appetite(n=138)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Irritability(n=138)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Increased sleep(n=138)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}]}]}, {'title': 'Decreased sleep(n=139)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Hives (urticaria)(n=138)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=138)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Any systemic event(n=141)', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 2', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'classes': [{'title': 'Fever >=37.5 but =<39 degrees C(n=134)', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Fever >39 but =<40.0 degrees C(n=130)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Fever >40 degrees C(n=130)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Decreased appetite(n=130)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Irritability(n=131)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'Increased sleep(n=131)', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Decreased sleep(n=131)', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Hives (urticaria)(n=131)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Antipyretic medication to treat symptom(n=130)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Any systemic event(n=136)', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Catch-up Dose 3', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'FG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Randomized, Not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'After Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '7vPnC + DTaP', 'description': 'Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.'}, {'id': 'BG001', 'title': 'DTaP (Catch-up 7vPnC)', 'description': 'Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '0.94', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '0.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2010-11-29', 'resultsFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-22', 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 1', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 2', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 3', 'description': 'Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters \\[cm\\]); Moderate (2.5 to 7.0 cm); Severe (\\> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)', 'timeFrame': 'Within 7 days after Dose 1 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)', 'timeFrame': 'Within 7 days after Dose 2 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)', 'timeFrame': 'Within 7 days after Dose 3 of the infant series', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)', 'timeFrame': 'Within 7 days after the toddler dose', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 1', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 2', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)', 'timeFrame': 'Within 7 days after Catch-up Dose 3', 'description': 'Systemic events (any fever \\>= 37.5 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \\[urticaria\\]), were reported using an electronic diary. Participants may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.'}, {'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series', 'description': 'Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.'}, {'measure': 'Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.'}, {'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose', 'description': 'Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose', 'timeFrame': 'Pre-toddler dose, 1 month after the toddler dose', 'description': 'Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.'}, {'measure': 'Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3', 'timeFrame': '1 month after the catch-up dose 3', 'description': 'Percentage of participants achieving predefined antibody threshold \\>=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3', 'timeFrame': '1 month after the catch-up dose 3', 'description': 'Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaccine', 'pneumococcal conjugate'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1841007&StudyName=A%20Trial%20Evaluating%20a%207-valent%20Pneumococcal%20Conjugate%20Vaccine%20Given%20with%20Diphtheria%2C%20Tetanus%2C%20and%20Acellular%20Pertussis%20Vaccine%20%28DTaP%29%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.\n* Available for entire study period and whose parent/legal guardian can be reached by telephone.\n* Healthy infant as determined by medical history, physical examination, and judgment of the investigator.\n\nExclusion Criteria:\n\n* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.\n* A previous anaphylactic reaction to any vaccine or vaccine-related component.\n* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.\n* History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).\n* Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.'}, 'identificationModule': {'nctId': 'NCT01250756', 'briefTitle': 'A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.', 'orgStudyIdInfo': {'id': 'B1841007'}, 'secondaryIdInfos': [{'id': 'B1841007, 6107A1-4000'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Experimental', 'interventionNames': ['Biological: 7-pneumococcal conjugate vaccine (7vPnC)', 'Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Active comparator', 'interventionNames': ['Biological: DTaP']}], 'interventions': [{'name': '7-pneumococcal conjugate vaccine (7vPnC)', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['1']}, {'name': 'diphtheria, tetanus, and acellular pertussis vaccine (DTaP)', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['1']}, {'name': 'DTaP', 'type': 'BIOLOGICAL', 'description': '0.5 mL per dose, 4 doses', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': "Tsubaki Children's Clinic", 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Isumi', 'state': 'Chiba', 'country': 'Japan', 'facility': "Sotobo Children's Clinic", 'geoPoint': {'lat': 35.23005, 'lon': 140.40492}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Matsuyama Red Cross Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kiyomatsu Childrens Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Fukuoka National Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': "Shindo Children's Clinic", 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Takasaki Clinic Pedatrics and Child Health', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Itoshima', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Yamashita Pediatrics Clinic', 'geoPoint': {'lat': 33.54225, 'lon': 130.18421}}, {'city': 'Kasuga', 'state': 'Fukuoka', 'country': 'Japan', 'facility': "Yokoyama Children's Clinic", 'geoPoint': {'lat': 33.52594, 'lon': 130.4611}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': "Furuta Children's Clinic", 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Tenshi Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Watanabe Pediatric Allergy Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Yamanaka Tatsuru Pediatrics', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kuwana', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Matsuda Pediatrics Clinic', 'geoPoint': {'lat': 35.05192, 'lon': 136.66958}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kawasaki Medical School, Department of Pediatrics', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Momotaro Clinic', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Hug Hug Kids Clinic', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'city': 'Kumagaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Shibuya Clinic', 'geoPoint': {'lat': 36.13497, 'lon': 139.39004}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}