Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 10:05 AM
Study NCT ID:
NCT04816669
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090982', 'term': 'BNT162 Vaccine'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patients@biontech.de', 'phone': '+49 6131 9084', 'title': 'BioNTech clinical trials patient information', 'phoneExt': '0', 'organization': 'BioNTech SE'}, 'certainAgreement': {'otherDetails': 'BioNTech SE 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 and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.', 'otherNumAtRisk': 279, 'deathsNumAtRisk': 279, 'otherNumAffected': 262, 'seriousNumAtRisk': 279, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.', 'otherNumAtRisk': 280, 'deathsNumAtRisk': 280, 'otherNumAffected': 274, 'seriousNumAtRisk': 280, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 33, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 31, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 87, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Suspected COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Sinusitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Bacterial vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Tonsillar inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Diarrhoea (DIARRHEA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vomiting (VOMITING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Chills (CHILLS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 148}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 233}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site pain (PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 240}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 261}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Pyrexia (FEVER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Arthralgia (JOINT PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Myalgia (MUSCLE PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 153}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Headache (HEADACHE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 279, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 280, 'numAffected': 198}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '4796.8', 'groupId': 'OG000', 'lowerLimit': '4414.1', 'upperLimit': '5212.8'}, {'value': '7031.6', 'groupId': 'OG001', 'lowerLimit': '6393.6', 'upperLimit': '7733.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.77', 'estimateComment': 'GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month after Dose 2', 'description': 'GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.', 'unitOfMeasure': 'Unit per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'Redness', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '8.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '6.5'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '6.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.2'}]}]}, {'title': 'Pain at Injection Site', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '82.8'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '90.8'}, {'value': '85.7', 'groupId': 'OG002', 'lowerLimit': '69.7', 'upperLimit': '95.2'}, {'value': '68.6', 'groupId': 'OG003', 'lowerLimit': '50.7', 'upperLimit': '83.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'Redness', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.6'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '8.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.7'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '23.1'}]}]}, {'title': 'Pain at Injection Site', 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '65.4', 'upperLimit': '76.5'}, {'value': '80.3', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '84.8'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '85.4'}, {'value': '62.9', 'groupId': 'OG003', 'lowerLimit': '44.9', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'Fever >=38.0 degree C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '52.5'}, {'value': '57.5', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '63.4'}, {'value': '54.3', 'groupId': 'OG002', 'lowerLimit': '36.6', 'upperLimit': '71.2'}, {'value': '45.7', 'groupId': 'OG003', 'lowerLimit': '28.8', 'upperLimit': '63.4'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '37.1'}, {'value': '44.3', 'groupId': 'OG001', 'lowerLimit': '38.4', 'upperLimit': '50.3'}, {'value': '37.1', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '55.1'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '16.9', 'upperLimit': '49.3'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '12.6'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '23.6'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '23.1'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '23.1'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.6'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '4.6'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.2'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '14.9'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '19.1'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '18.5'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '19.2'}, {'value': '11.4', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '26.7'}]}]}, {'title': 'New or worsened muscle pain', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '21.4'}, {'value': '27.1', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '32.8'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '36.9'}]}]}, {'title': 'New or worsened joint pain', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '11.7'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '20.1'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '17.1', 'groupId': 'OG003', 'lowerLimit': '6.6', 'upperLimit': '33.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 1', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'Fever >=38.0 degree C', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '9.7'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '16.9'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '14.9'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.2'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '66.8'}, {'value': '75.2', 'groupId': 'OG001', 'lowerLimit': '69.6', 'upperLimit': '80.2'}, {'value': '48.6', 'groupId': 'OG002', 'lowerLimit': '31.4', 'upperLimit': '66.0'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '42.1', 'upperLimit': '76.1'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '54.3'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '55.6', 'upperLimit': '67.5'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '23.9', 'upperLimit': '57.9'}, {'value': '40.0', 'groupId': 'OG003', 'lowerLimit': '23.9', 'upperLimit': '57.9'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '33.4'}, {'value': '46.4', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '52.4'}, {'value': '22.9', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '40.1'}, {'value': '17.1', 'groupId': 'OG003', 'lowerLimit': '6.6', 'upperLimit': '33.6'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '4.7'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '14.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '17.3'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '19.3'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '23.1'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '4.8', 'upperLimit': '30.3'}]}]}, {'title': 'New or worsened muscle pain', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '38.8'}, {'value': '43.1', 'groupId': 'OG001', 'lowerLimit': '37.1', 'upperLimit': '49.2'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '36.9'}, {'value': '37.1', 'groupId': 'OG003', 'lowerLimit': '21.5', 'upperLimit': '55.1'}]}]}, {'title': 'New or worsened joint pain', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '21.8'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '38.0'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '46.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 2', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Before Dose 1 on Day 1)', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Unit per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '2189.0', 'groupId': 'OG000', 'lowerLimit': '1841.6', 'upperLimit': '2601.9'}, {'value': '3194.0', 'groupId': 'OG001', 'lowerLimit': '2665.8', 'upperLimit': '3826.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '7773.3', 'groupId': 'OG000', 'lowerLimit': '5758.5', 'upperLimit': '10493.1'}, {'value': '6839.9', 'groupId': 'OG001', 'lowerLimit': '5242.9', 'upperLimit': '8923.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.68', 'estimateComment': 'GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 Month after Dose 2', 'description': 'GMTs of full-length S-binding IgG level for frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs were reported in this outcome measure as GMCs in descriptive data section. GMC and 95 % CI were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMR was calculated as ratios of GMCs of BNT162b2 30 mcg frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs. GMR are reported in the statistical analysis section.', 'unitOfMeasure': 'Unit per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.7'}]}]}, {'title': '1 Month after Dose 2', 'categories': [{'measurements': [{'value': '7773.3', 'groupId': 'OG000', 'lowerLimit': '5758.5', 'upperLimit': '10493.1'}, {'value': '6839.9', 'groupId': 'OG001', 'lowerLimit': '5242.9', 'upperLimit': '8923.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Unit per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'OG001', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '3339.1', 'groupId': 'OG000', 'lowerLimit': '1662.6', 'upperLimit': '6706.4'}, {'value': '2072.1', 'groupId': 'OG001', 'lowerLimit': '987.5', 'upperLimit': '4348.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.'}], 'classes': [{'title': 'Redness', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '13.0'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '13.0'}]}]}, {'title': 'Pain at Injection Site', 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '78.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.'}], 'classes': [{'title': 'Fever >=38.0 degree C', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '15.4'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '72.6'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '62.1'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '49.2'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '8.0'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '21.0'}]}]}, {'title': 'New or worsened muscle pain', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '38.5'}]}]}, {'title': 'New or worsened joint pain', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '25.3'}]}]}, {'title': 'Use of antipyretic or pain medication', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '45.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Dose 3', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 3 were reported.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Dose 3 up to 1 Month after Dose 3 (1 month)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '18.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From before Dose 3 to 1 Month after Dose 3', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG from 1 month after Dose 3 to geometric mean concentration of IgG before Dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:Participants who were eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,were negative for both SARS-CoV-2 tests at Day 1 and 1 month post-Dose 3 visits, and had no other important protocol deviations as determined by clinician.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BNT162b2 Frozen-Liquid MDV: Dose 3', 'description': 'Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.7'}]}]}, {'title': '1 Month after Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4612.2', 'groupId': 'OG000', 'lowerLimit': '4065.7', 'upperLimit': '5232.1'}]}]}, {'title': 'Before Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '874.4', 'groupId': 'OG000', 'lowerLimit': '735.6', 'upperLimit': '1039.4'}]}]}, {'title': '1 Month after Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14006.7', 'groupId': 'OG000', 'lowerLimit': '11902.7', 'upperLimit': '16482.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.', 'unitOfMeasure': 'Unit per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population:Participants eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,negative for both SARS-CoV-2 tests at Day 1,1 month post Dose 3 visits, had no other important protocol deviations determined by clinician. Here, n= participants evaluable for specific timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BNT162b2 Lyophilized Single Dose Vial (SDV): Part 1', 'description': 'Participants were randomized to receive 30 microgram (mcg) intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine. Participants after receiving 2 doses of lyophilized formulation of BNT162b2 and who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'FG001', 'title': 'BNT162b2 Frozen-Liquid Multi Dose Vial (MDV): Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'FG002', 'title': 'BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'FG003', 'title': 'BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccinated at Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccinated at Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '277'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Vaccination at Dose 3', 'achievements': [{'comment': 'Participants who received 2 doses of lyophilized formulation of BNT162b2 in Part 1, were offered to receive Dose 3 of frozen-liquid formulation.', 'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '274'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Vaccinated at Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Vaccinated at Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study was conducted in two parts: Part 1 and Part 2. Participants who received 2 doses of lyophilized formulation of BNT162b2 in Part 1, were offered to receive Dose 3 of frozen-liquid formulation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '629', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BNT162b2 Lyophilized SDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.'}, {'id': 'BG001', 'title': 'BNT162b2 Frozen-Liquid MDV: Part 1', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'BG002', 'title': 'BNT162b2 Frozen-Liquid With LNP Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'BG003', 'title': 'BNT162b2 Frozen-Liquid With RTU Size: Part 2', 'description': 'Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '629', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '307', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '495', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '500', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population set included all randomized participants who received at least 1 dose of the study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-13', 'size': 2621800, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-30T09:45', 'hasProtocol': True}, {'date': '2021-05-05', 'size': 1719420, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-30T09:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 629}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-30', 'studyFirstSubmitDate': '2021-03-24', 'resultsFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-30', 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2', 'timeFrame': '1 Month after Dose 2', 'description': 'GMTs of full-length S-binding IgG level for frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs were reported in this outcome measure as GMCs in descriptive data section. GMC and 95 % CI were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. GMR was calculated as ratios of GMCs of BNT162b2 30 mcg frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs. GMR are reported in the statistical analysis section.'}, {'measure': 'GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2', 'timeFrame': 'Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}, {'measure': 'GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2', 'timeFrame': 'From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}, {'measure': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 3', 'timeFrame': 'Within 7 days after Dose 3', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3.'}, {'measure': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 3', 'timeFrame': 'Within 7 days after Dose 3', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 3 were reported.'}, {'measure': 'Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3', 'timeFrame': 'Dose 3 up to 1 Month after Dose 3 (1 month)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.'}, {'measure': 'GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3', 'timeFrame': 'From before Dose 3 to 1 Month after Dose 3', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG from 1 month after Dose 3 to geometric mean concentration of IgG before Dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}, {'measure': 'GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3', 'timeFrame': 'Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2', 'timeFrame': '1 Month after Dose 2', 'description': 'GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.'}, {'measure': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 1', 'timeFrame': 'Within 7 days after Dose 1', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.'}, {'measure': 'Percentage of Participants With Local Reactions Within 7 Days After Dose 2', 'timeFrame': 'Within 7 days after Dose 2', 'description': 'Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.'}, {'measure': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 1', 'timeFrame': 'Within 7 days after Dose 1', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.'}, {'measure': 'Percentage of Participants With Systemic Events Within 7 Days After Dose 2', 'timeFrame': 'Within 7 days after Dose 2', 'description': 'Systemic events were reported using an electronic diary. Fever was defined as temperature \\>=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2', 'timeFrame': 'Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1', 'timeFrame': 'Baseline (Before Dose 1 on Day 1)', 'description': 'GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}, {'measure': 'Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1', 'timeFrame': 'From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2', 'description': 'GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\\*LLOQ.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Coronavirus', 'Vaccine', 'SARS-CoV-2', 'RNA Vaccine'], 'conditions': ['SARS-CoV-2 Infection', 'COVID-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4591020', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2.\n\n* 2-dose schedule (separated by 21 days)\n* At a dose of 30µg (as studied in the Phase 2/3 study C4591001)\n* In healthy adults 18 through 55 years of age\n* The duration of the study for each participant will be approximately 2 months (3 visits in total)\n* The study will be conducted in the United States'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.\n* Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.\n* For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.\n\nExclusion Criteria:\n\n* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Known infection with HIV, HCV, or HBV.\n* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).\n* Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.\n* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.\n* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* Women who are pregnant or breastfeeding.\n* Previous vaccination with any coronavirus vaccine.\n* Receipt of medications intended to prevent COVID-19.\n* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.\n* Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.\n* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation / Previous participation in other studies involving study intervention containing lipid nanoparticles (LNPs).\n* Previous participation in other studies involving study intervention containing lipid nanoparticles.\n* Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members."}, 'identificationModule': {'nctId': 'NCT04816669', 'briefTitle': 'A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioNTech SE'}, 'officialTitle': 'A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'C4591020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lyophilized SDV', 'interventionNames': ['Biological: BNT162b2']}, {'type': 'EXPERIMENTAL', 'label': 'Frozen liquid MDV (control for lyo SDV)', 'description': 'Control for lyophilized SDV', 'interventionNames': ['Biological: BNT162b2']}, {'type': 'EXPERIMENTAL', 'label': 'Frozen-liquid with LNP size at the upper end of specification', 'interventionNames': ['Biological: BNT162b2']}, {'type': 'EXPERIMENTAL', 'label': 'RTU', 'interventionNames': ['Biological: BNT162b2']}, {'type': 'EXPERIMENTAL', 'label': 'Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)', 'description': 'Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2', 'interventionNames': ['Biological: BNT162b2']}], 'interventions': [{'name': 'BNT162b2', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection', 'armGroupLabels': ['Frozen liquid MDV (control for lyo SDV)', 'Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)', 'Frozen-liquid with LNP size at the upper end of specification', 'Lyophilized SDV', 'RTU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health Center, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America ( Hollywood )', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc. dba CNS Healthcare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Solaris Clinical Research', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Pediatric/ Adult Research', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08869', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amici Clinical Research LLC', 'geoPoint': {'lat': 40.56955, 'lon': -74.63294}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Accellacare (formerly PMG Research of Wilmington, LLC)', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Benchmark Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Center for Drug Development, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research (Administrative and Storage Office only)', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Martin Diagnostic Clinic', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioNTech SE', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}