Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT03188666
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2017-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
Sponsor:
Organization:
Raw JSON
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The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to end of study', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks during Period 2 followed by 20 weeks during Period 3. Participants could continue receiving REGN2477 every 4 weeks beyond week 76 provided that no safety signals were identified.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 3, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 24, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 18, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 22, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Muscle swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Calcification of muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Coccydynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Inguinal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Joint noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Muscle spasms', 'stats': 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'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tendon pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 28, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 47, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acquired phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Endometrial thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Perineal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'title': 'Participants with at least one TEAE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Participants with at least one serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': 'Treatment-emergent adverse events (TEAEs) are adverse events not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious TEAE was defined as any untoward medical occurrence that resulted in any of following outcomes not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. Number of participants with TEAEs and Serious TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received any study drug and was analyzed as treated.'}, {'type': 'PRIMARY', 'title': 'Period 1: Number of Participants With TEAEs by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'title': 'Participants with at least one Mild TEAE', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Participants with at least one Moderate TEAE', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Participants with at least one Severe TEAE', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 28', 'description': "Severity of TEAEs were graded as follows: Mild: Does not interfere in a significant manner with the participant's normal functioning level. It may be an annoyance. Prescription drugs are not ordinarily needed for relief of symptoms but may be given because of personality of the participants. Moderate: Produces some impairment of functioning but is not hazardous to health. It was uncomfortable or an embarrassment. Treatment for symptom may be needed. Severe: Produces significant impairment of functioning or incapacitation and was a definite hazard to the participant's health. Treatment for symptom may be given and/or participants hospitalized. Number of participants with TEAEs by severity is reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received any study drug and was analyzed as treated.'}, {'type': 'PRIMARY', 'title': 'Period 1: Time-Weighted Average (Standardized Area Under the Curve [AUC]) of the Percent Change From Baseline in Total Lesion Activity by Fluorine-18-labeled Sodium Fluoride (18^F-NaF) Positron Emission Tomography (PET) at Week 28 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '9.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.6', 'ciLowerLimit': '-51.8', 'ciUpperLimit': '2.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 28', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Time-weighted average (standardized area under the curve \\[AUC\\]) of the percent change from baseline in total lesion activity by 18\\^F-NaF PET up to Week 28 in AHO analysis set is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline-active heterotopic ossification analysis set (AHO) included all randomized participants who had at least one active HO lesion at baseline; and was based on the treatment allocated (as randomized).'}, {'type': 'PRIMARY', 'title': 'Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by Computed Tomography (CT) at Week 28 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '18.66', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '20.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3726', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.9', 'ciLowerLimit': '-80.8', 'ciUpperLimit': '30.9', 'statisticalMethod': 'Mixed Model with Repeated Measure (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions as assessed by CT during Period 1 at Week 28 is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AHO analysis set included all randomized participants who had at least one active HO lesion at baseline was based on the treatment allocated (as randomized).'}, {'type': 'PRIMARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. HO detectable by CT that developed after baseline are referred to as "new HO lesions." Number of new HO lesions as assessed by CT at Week 56 relative to Week 28 scan is reported.', 'unitOfMeasure': 'New HO Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'PRIMARY', 'title': 'Period 1: Time-weighted Average (Standardized AUC) of the Percent Change From Baseline in Total Lesion Activity Assessed by 18^F-NaF PET at Week 28 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '10.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0756', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.6', 'ciLowerLimit': '-53.9', 'ciUpperLimit': '2.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Time-weighted average (Standardized AUC) of the percent change from baseline in total lesion activity as assessed by 18\\^F-NaF PET in Active HO Classic ACVR1 Mutation (AHOC) analysis set up to Week 28 is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT at Week 28 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '19.90', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '20.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.8', 'ciLowerLimit': '-86.1', 'ciUpperLimit': '30.5', 'statisticalMethod': 'Mixed Model with Repeated Measure (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions was assessed by CT at Week 28 in AHOC analysis set is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to Fibrodysplasia Ossificans Progressiva (FOP) Assessed by Daily Numeric Rating Scale (NRS) at Week 28 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.231', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2656', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.27', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28', 'description': 'The pain NRS is a patient reported outcome (PRO) used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome. Time-weighted average (Standardized AUC) of the change from baseline in daily pain due to FOP assessed by daily NRS at Week 28 in AHO analysis set is reported.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to FOP, Assessed by Daily NRS at Week 28 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.221', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.237', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 28', 'description': 'The pain NRS is a PRO used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome. Time-Weighted average (standardized AUC) of the change from baseline in daily pain due to FOP assessed by daily NRS at Week 28 in AHOC analysis set is reported.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) Assessed by 18^F-NaF PET at Week 8 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '28.79', 'groupId': 'OG000'}, {'value': '-21.6', 'spread': '30.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Standardized uptake value max (SUVmax) was a measurement of the maximum radiopharmaceutical uptake within the volume of interest. Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT. Percent Change in 18\\^F-NaF SUVmax of Individual Active HO Site(s) assessed by 18\\^F-NaF PET in AHOC analysis set is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) as Assessed by 18^F-NaFPET at Week 8 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'spread': '28.80', 'groupId': 'OG000'}, {'value': '-21.6', 'spread': '30.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Percent change in 18\\^F-NaF SUVmax of individual active HO site(s) as assessed by 18\\^F-NaF PET at Week 8 in AHO analysis set is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized).'}, {'type': 'SECONDARY', 'title': 'Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28', 'description': 'Change from baseline in number of HO lesions was assessed by 18\\^F-NaF PET at Week 28 in AHOC analysis set is reported.', 'unitOfMeasure': 'HO Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28', 'description': 'Change from baseline in number of HO lesions was assessed by 18\\^F-NaF PET in AHO analysis set is reported.', 'unitOfMeasure': 'HO Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized).'}, {'type': 'SECONDARY', 'title': 'Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Change from baseline in number of HO lesions was detectable by CT using AHOC analysis set is reported.', 'unitOfMeasure': 'HO Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHOC analysis set included all randomized participants with the classic ACVR1 \\[R206H\\] mutation and who had at least one AHO at baseline, as defined by 18\\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Change from baseline in number of HO lesions detectable by CT at Week 28 in AHO analysis set is reported.', 'unitOfMeasure': 'HO Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized).'}, {'type': 'SECONDARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': 'Number of new HO lesions as assessed by 18\\^F-NaF PET at Week 56 Relative to Week 28 Scan is reported.', 'unitOfMeasure': 'New HO lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percentage of participants with new HO lesions as assessed by CT at week 56 relative to week 28 scan is reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0047', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Percentage of participants with new HO lesions as assessed by 18\\^F-NaF PET at week 56 relative to week 28 scan is reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to positron-emission tomography (PET). Number of new HO lesions as assessed by CT only at week 56 relative to week 28 scan is reported.', 'unitOfMeasure': 'New HO lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET). Percentage of participants with new HO lesions as assessed by CT only at week 56 relative to week 28 scan is reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3663', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Period 2 vs. Period 1', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Difference of Change from Week 28 to Week 56 as assessed by 18\\^F-NaF PET versus from Baseline to Week 28', 'unitOfMeasure': 'Active lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by CT Scan at Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Period 2 vs. Period 1', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Difference of Change from Week 28 to Week 56 as assessed by CT Scan versus from Baseline to Week 28 is reported', 'unitOfMeasure': 'Active lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan is collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Number of new HO lesions as assessed by CT at week 56 relative to baseline.', 'unitOfMeasure': 'New HO Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 only (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET); Number of new HO lesions as assessed by CT only at week 56 relative baseline is reported.', 'unitOfMeasure': 'New HO Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who receive a treatment in Period 2 for whom at least 1 post-Week 28 scan is collected and the period between any consecutive doses is less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percentage of participants with new HO lesions as assessed by CT at week 56 relative to baseline were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Number of New HO Lesions as Assessed by 18^F-NAF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Number of new HO lesions as assessed by 18\\^F-NAF PET at week 56 relative to baseline is reported.', 'unitOfMeasure': 'New HO Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Percentage of participants with new HO lesions as assessed by 18\\^F-NaF PET at week 56 relative to baseline.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Total Volume of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Total volume of new HO lesions as assessed by CT at Week 56 relative to Week 28 scan.', 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Total Lesion Activity (TLA) Assessed by 18^F-NaF PET in New HO Lesions at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '61.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0273', 'groupIds': ['OG000'], 'pValueComment': 'Week 56 vs. Week 28', 'groupDescription': 'Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': 'TLA is a measure of participant-level cumulative burden of metabolically active HO. Activity of individual HO lesions was calculated as the product of mean standard uptake value (SUVmean) and the PET volume of the active HO lesion. TLA was derived for each participant at each time point as the sum of HO lesion activity of individual target and new active HO lesions.', 'unitOfMeasure': 'gram (g)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2 vs. Period 1: Percent Change From Week 28 in TLA as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.9', 'spread': '181.06', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '41.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2123', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Period 2 vs. Period 1', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': 'Difference of Percent Change from Week 28 to Week 56 versus from Baseline to Week 28 is reported', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2 vs. Period 1: Percent Change From Week 28 in the Total Volume of HO Lesions as Assessed by CT to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.8', 'spread': '132.47', 'groupId': 'OG000'}, {'value': '-11.1', 'spread': '24.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1528', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Period 2 vs. Period 1', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Difference of Percent Change from Week 28 to Week 56 versus from Baseline to Week 28 is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2: TLA in New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/ REGN2477', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single-dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '2.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56', 'description': 'Total Lesion Activity (TLA) is a measure of participant-level cumulative burden of metabolically active HO. TLA in New (Relative to Baseline) Lesions at Week 56 is reported.', 'unitOfMeasure': 'gram (g)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Total Volume of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET); Total volume of new HO lesions as assessed by CT only at week 56 relative to baseline is reported.', 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percent Change From Baseline in TLA as Assessed by 18^F-NaF PET to Week 56 (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'spread': '53.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56', 'description': 'Percent change from baseline in TLA as assessed by 18\\^F-NaF PET to week 56 were reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT to Week 56 (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '10.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions as assessed by CT to Week 56 were reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percent Change From Week 28 in SUVmax as Assessed by 18^F-NaF to Week 56 (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.3', 'spread': '15.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percent Change from Week 28 to Week 56 is reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percent Change From Baseline in 18^F-NaF PET SUVmax to Week 56 (AHO COVID-19 mITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.9', 'spread': '29.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 56', 'description': 'Percent change from baseline in 18\\^F-NaF PET SUVmax to week 56', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to week 28 for participants on treatment during period 2 (Placebo/REGN2477) as planned.'}, {'type': 'SECONDARY', 'title': 'Period 2: Daily Average Pain Due to FOP Measured Using the Daily NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '1.969', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28 up to Week 56', 'description': 'The pain NRS is a patient reported outcome used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With Flare-ups Assessed by Participant E-diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percentage of participants with flare-ups starting between week 28 and week 56 as assessed by participant E-diary is reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Period 2: Percentage of Participants With Investigator-assessed Flare-ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percentage of participants with investigator-assessed flare-ups were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Data were planned to be collected and analyzed only for participants switching to REGN2477 in period 2 for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Periods 1, 2, and 3: Concentration of Total Activin A in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000813', 'spread': '0.000164', 'groupId': 'OG000'}, {'value': '0.0537', 'spread': '0.0116', 'groupId': 'OG001'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0563', 'spread': '0.0172', 'groupId': 'OG000'}, {'value': '0.0503', 'spread': '0.0113', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0487', 'spread': '0.0192', 'groupId': 'OG000'}, {'value': '0.0497', 'spread': '0.0176', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56, Week 76', 'description': 'Concentration of total activin A in serum over time is reported.', 'unitOfMeasure': 'milligram per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration following the first dose of study drug. ("Number Analyzed" equals number of participants evaluable at that time point)'}, {'type': 'SECONDARY', 'title': 'Periods 1, 2, and 3: Concentrations of Functional REGN2477 in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to Week 56) during Period 2.'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '130', 'spread': '46.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '122', 'spread': '54.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '113', 'spread': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 28, Week 56, Week 76', 'description': 'Concentrations of REGN2477 capable of target binding were measured (functional drug).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration following the first dose of study drug. ("Number Analyzed" equals number of participants evaluable at that time point)'}, {'type': 'SECONDARY', 'title': 'Periods 1, 2, and 3: Number of Participants With Clinical Impact of Treatment-Emergent Anti-drug Antibodies (ADA) to REGN2477', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'OG001', 'title': 'REGN2477/ REGN2477', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single-dose of REGN2477 IV infusion Q4W for additional 28 weeks (up to week 56) during Period 2.'}], 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Pre-existing Immunoreactivity', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Treatment-Boosted Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Treatment-Emergent Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 76', 'description': 'Immunogenicity was characterized by ADA responses \\& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \\< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \\>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the REGN2477 ADA assay post first dose when baseline results = negative or missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Anti-Drug Antibody (ADA) analysis set included all participants who received study drug and had at least 1 non-missing ADA result following the first study dose. "Overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'FG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'FG002', 'title': 'Placebo/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the placebo group in Period 1 crossed over to receive a single dose of REGN2477 IV infusion Q4W for 28 weeks during Period 2 followed by 20 weeks during Period 3.'}, {'id': 'FG003', 'title': 'REGN2477/REGN2477 10 mg/kg Q4W', 'description': 'Participants who were in the REGN2477 group in Period 1 continued treatment with a single dose of REGN2477 IV infusion Q4W for additional 28 weeks during Period 2 followed by 20 weeks during Period 3.'}], 'periods': [{'title': 'Period 1 (28 Weeks Double-blind)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (28 Weeks Open-label)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 3 (20 Weeks Follow-up)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 48 participants were screened, out of which, 44 participants were randomized and treated.', 'preAssignmentDetails': 'This was a three period study design which consisted of a 6-month (28 weeks), randomized, double-blind placebo-controlled treatment period (Period 1) followed by a 6-month (28 weeks), open-label treatment period (Period 2) and a 20 week follow-up treatment period (Period 3). Participants could continue receiving REGN2477 every 4 weeks beyond week 76 provided that no safety signals were identified.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo matched to REGN2477 intravenous (IV) infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'BG001', 'title': 'REGN2477 10 mg/kg Q4W', 'description': 'Participants received a single dose of REGN2477 10 milligrams per kilogram (mg/kg) IV infusion every 4 weeks (Q4W) for up to 28 weeks during Period 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '8.54', 'groupId': 'BG000'}, {'value': '27.3', 'spread': '8.67', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '8.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Lesion Activity by fluorine-18 sodium fluoride (18 F-NaF) PET (AHO Analysis Set)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '473.40', 'spread': '348.373', 'groupId': 'BG000'}, {'value': '418.18', 'spread': '372.801', 'groupId': 'BG001'}, {'value': '448.30', 'spread': '356.510', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '18\\^F-NaF positron emission tomography (PET) imaging was used to assess lesion and disease activity.', 'unitOfMeasure': 'gram (g)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The baseline-active HO analysis set (AHO) includes all randomized patients who had at least one active HO lesion at baseline; it is based on the treatment allocated (as randomized).'}, {'title': 'Total Volume of HO Lesions as Assessed by Computed Tomography (CT) (AHO Analysis Set)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '235.78', 'spread': '253.329', 'groupId': 'BG000'}, {'value': '251.43', 'spread': '327.881', 'groupId': 'BG001'}, {'value': '242.89', 'spread': '286.167', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. The baseline-Active Heterotopic ossification (AHO) analysis set includes all randomized patients who had at least one active HO lesion at baseline; it is based on the treatment allocated (as randomized).', 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Lesion Activity by 18F-NaF PET (AHOC Analysis Set)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '464.27', 'spread': '350.479', 'groupId': 'BG000'}, {'value': '418.18', 'spread': '372.801', 'groupId': 'BG001'}, {'value': '442.32', 'spread': '357.581', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '18\\^F-NaF positron emission tomography (PET) imaging was used to assess lesion and disease activity.', 'unitOfMeasure': 'gram (g)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The baseline-active HO classic ACVR1 \\[R206H\\] mutation analysis set (AHOC) includes all randomized patients with the classic ACVR1 \\[R206H\\] mutation and who had at least one active HO lesion(s) at baseline, as defined by 18F-NaF PET positivity; it is based on the treatment allocated (as randomized)'}, {'title': 'Total Volume of HO Lesions as Assessed by CT (AHOC Analysis Set)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '239.72', 'spread': '263.813', 'groupId': 'BG000'}, {'value': '251.43', 'spread': '327.881', 'groupId': 'BG001'}, {'value': '245.29', 'spread': '292.408', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan.', 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The baseline-active HO classic ACVR1 \\[R206H\\] mutation analysis set (AHOC) includes all randomized patients with the classic ACVR1 \\[R206H\\] mutation and who had at least one active HO lesion(s) at baseline, as defined by 18F-NaF PET positivity; it is based on the treatment allocated (as randomized)'}, {'title': 'Fibrodysplasia Ossificans Progressiva (FOP) Genetic Mutation', 'classes': [{'title': 'Active HO classic ACVR1 (R206H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included all randomized participants and was based on the treatment allocated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-28', 'size': 1137458, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-15T09:43', 'hasProtocol': True}, {'date': '2020-10-23', 'size': 1415830, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-15T09:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2020-09-15', 'completionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2017-06-13', 'dispFirstSubmitQcDate': '2022-11-04', 'resultsFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2017-06-13', 'dispFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-04', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Up to Week 28', 'description': 'Treatment-emergent adverse events (TEAEs) are adverse events not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious TEAE was defined as any untoward medical occurrence that resulted in any of following outcomes not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. Number of participants with TEAEs and Serious TEAEs are reported.'}, {'measure': 'Period 1: Number of Participants With TEAEs by Severity', 'timeFrame': 'Up to Week 28', 'description': "Severity of TEAEs were graded as follows: Mild: Does not interfere in a significant manner with the participant's normal functioning level. It may be an annoyance. Prescription drugs are not ordinarily needed for relief of symptoms but may be given because of personality of the participants. Moderate: Produces some impairment of functioning but is not hazardous to health. It was uncomfortable or an embarrassment. Treatment for symptom may be needed. Severe: Produces significant impairment of functioning or incapacitation and was a definite hazard to the participant's health. Treatment for symptom may be given and/or participants hospitalized. Number of participants with TEAEs by severity is reported."}, {'measure': 'Period 1: Time-Weighted Average (Standardized Area Under the Curve [AUC]) of the Percent Change From Baseline in Total Lesion Activity by Fluorine-18-labeled Sodium Fluoride (18^F-NaF) Positron Emission Tomography (PET) at Week 28 (AHO)', 'timeFrame': 'Baseline and Week 28', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Time-weighted average (standardized area under the curve \\[AUC\\]) of the percent change from baseline in total lesion activity by 18\\^F-NaF PET up to Week 28 in AHO analysis set is reported.'}, {'measure': 'Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by Computed Tomography (CT) at Week 28 (AHO)', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions as assessed by CT during Period 1 at Week 28 is reported.'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. HO detectable by CT that developed after baseline are referred to as "new HO lesions." Number of new HO lesions as assessed by CT at Week 56 relative to Week 28 scan is reported.'}, {'measure': 'Period 1: Time-weighted Average (Standardized AUC) of the Percent Change From Baseline in Total Lesion Activity Assessed by 18^F-NaF PET at Week 28 (AHOC)', 'timeFrame': 'Week 28', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Time-weighted average (Standardized AUC) of the percent change from baseline in total lesion activity as assessed by 18\\^F-NaF PET in Active HO Classic ACVR1 Mutation (AHOC) analysis set up to Week 28 is reported.'}, {'measure': 'Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT at Week 28 (AHOC)', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions was assessed by CT at Week 28 in AHOC analysis set is reported.'}], 'secondaryOutcomes': [{'measure': 'Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to Fibrodysplasia Ossificans Progressiva (FOP) Assessed by Daily Numeric Rating Scale (NRS) at Week 28 (AHO)', 'timeFrame': 'Week 28', 'description': 'The pain NRS is a patient reported outcome (PRO) used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome. Time-weighted average (Standardized AUC) of the change from baseline in daily pain due to FOP assessed by daily NRS at Week 28 in AHO analysis set is reported.'}, {'measure': 'Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to FOP, Assessed by Daily NRS at Week 28 (AHOC)', 'timeFrame': 'Week 28', 'description': 'The pain NRS is a PRO used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome. Time-Weighted average (standardized AUC) of the change from baseline in daily pain due to FOP assessed by daily NRS at Week 28 in AHOC analysis set is reported.'}, {'measure': 'Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) Assessed by 18^F-NaF PET at Week 8 (AHOC)', 'timeFrame': 'Week 8', 'description': 'Standardized uptake value max (SUVmax) was a measurement of the maximum radiopharmaceutical uptake within the volume of interest. Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT. Percent Change in 18\\^F-NaF SUVmax of Individual Active HO Site(s) assessed by 18\\^F-NaF PET in AHOC analysis set is reported.'}, {'measure': 'Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) as Assessed by 18^F-NaFPET at Week 8 (AHO)', 'timeFrame': 'Week 8', 'description': 'Percent change in 18\\^F-NaF SUVmax of individual active HO site(s) as assessed by 18\\^F-NaF PET at Week 8 in AHO analysis set is reported.'}, {'measure': 'Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHOC)', 'timeFrame': 'Week 28', 'description': 'Change from baseline in number of HO lesions was assessed by 18\\^F-NaF PET at Week 28 in AHOC analysis set is reported.'}, {'measure': 'Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHO)', 'timeFrame': 'Week 28', 'description': 'Change from baseline in number of HO lesions was assessed by 18\\^F-NaF PET in AHO analysis set is reported.'}, {'measure': 'Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHOC)', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Change from baseline in number of HO lesions was detectable by CT using AHOC analysis set is reported.'}, {'measure': 'Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHO)', 'timeFrame': 'Week 28', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Change from baseline in number of HO lesions detectable by CT at Week 28 in AHO analysis set is reported.'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'Number of new HO lesions as assessed by 18\\^F-NaF PET at Week 56 Relative to Week 28 Scan is reported.'}, {'measure': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percentage of participants with new HO lesions as assessed by CT at week 56 relative to week 28 scan is reported.'}, {'measure': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Percentage of participants with new HO lesions as assessed by 18\\^F-NaF PET at week 56 relative to week 28 scan is reported.'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to positron-emission tomography (PET). Number of new HO lesions as assessed by CT only at week 56 relative to week 28 scan is reported.'}, {'measure': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET). Percentage of participants with new HO lesions as assessed by CT only at week 56 relative to week 28 scan is reported.'}, {'measure': 'Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Difference of Change from Week 28 to Week 56 as assessed by 18\\^F-NaF PET versus from Baseline to Week 28'}, {'measure': 'Period 2 vs. Period 1: Change From Week 28 in Number of Active HO Lesions as Assessed by CT Scan at Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Difference of Change from Week 28 to Week 56 as assessed by CT Scan versus from Baseline to Week 28 is reported'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Baseline, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Number of new HO lesions as assessed by CT at week 56 relative to baseline.'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET); Number of new HO lesions as assessed by CT only at week 56 relative baseline is reported.'}, {'measure': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percentage of participants with new HO lesions as assessed by CT at week 56 relative to baseline were reported.'}, {'measure': 'Period 2: Number of New HO Lesions as Assessed by 18^F-NAF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Number of new HO lesions as assessed by 18\\^F-NAF PET at week 56 relative to baseline is reported.'}, {'measure': 'Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': '18\\^F-NaF PET is used to assess lesion and disease activity. Percentage of participants with new HO lesions as assessed by 18\\^F-NaF PET at week 56 relative to baseline.'}, {'measure': 'Period 2: Total Volume of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Total volume of new HO lesions as assessed by CT at Week 56 relative to Week 28 scan.'}, {'measure': 'Period 2: Total Lesion Activity (TLA) Assessed by 18^F-NaF PET in New HO Lesions at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'TLA is a measure of participant-level cumulative burden of metabolically active HO. Activity of individual HO lesions was calculated as the product of mean standard uptake value (SUVmean) and the PET volume of the active HO lesion. TLA was derived for each participant at each time point as the sum of HO lesion activity of individual target and new active HO lesions.'}, {'measure': 'Period 2 vs. Period 1: Percent Change From Week 28 in TLA as Assessed by 18^F-NaF PET to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'Difference of Percent Change from Week 28 to Week 56 versus from Baseline to Week 28 is reported'}, {'measure': 'Period 2 vs. Period 1: Percent Change From Week 28 in the Total Volume of HO Lesions as Assessed by CT to Week 56 (Period 2) Versus the Same Participants Between Baseline and Week 28 (Period 1) (AHO COVID-19 mITT)', 'timeFrame': 'Week 28, Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Difference of Percent Change from Week 28 to Week 56 versus from Baseline to Week 28 is reported.'}, {'measure': 'Period 2: TLA in New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'Total Lesion Activity (TLA) is a measure of participant-level cumulative burden of metabolically active HO. TLA in New (Relative to Baseline) Lesions at Week 56 is reported.'}, {'measure': 'Period 2: Total Volume of New HO Lesions as Assessed by CT Only at Week 56 Relative to Baseline (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT Only: Computed Tomography (CT) assessment without reference to Positron-Emission Tomography (PET); Total volume of new HO lesions as assessed by CT only at week 56 relative to baseline is reported.'}, {'measure': 'Period 2: Percent Change From Baseline in TLA as Assessed by 18^F-NaF PET to Week 56 (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'Percent change from baseline in TLA as assessed by 18\\^F-NaF PET to week 56 were reported.'}, {'measure': 'Period 2: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT to Week 56 (AHO COVID-19 mITT)', 'timeFrame': 'Week 56', 'description': 'CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue, and blood vessels. CT scan acquired contemporaneously to the PET scan. Percent change from baseline in the total volume of HO lesions as assessed by CT to Week 56 were reported.'}, {'measure': 'Period 2: Percent Change From Week 28 in SUVmax as Assessed by 18^F-NaF to Week 56 (AHO COVID-19 mITT)', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percent Change from Week 28 to Week 56 is reported.'}, {'measure': 'Period 2: Percent Change From Baseline in 18^F-NaF PET SUVmax to Week 56 (AHO COVID-19 mITT)', 'timeFrame': 'Baseline, Week 56', 'description': 'Percent change from baseline in 18\\^F-NaF PET SUVmax to week 56'}, {'measure': 'Period 2: Daily Average Pain Due to FOP Measured Using the Daily NRS', 'timeFrame': 'Week 28 up to Week 56', 'description': 'The pain NRS is a patient reported outcome used by participants to rate their pain associated with FOP. Participants were asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain), where the highest score indicated worst outcome.'}, {'measure': 'Period 2: Percentage of Participants With Flare-ups Assessed by Participant E-diary', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percentage of participants with flare-ups starting between week 28 and week 56 as assessed by participant E-diary is reported.'}, {'measure': 'Period 2: Percentage of Participants With Investigator-assessed Flare-ups', 'timeFrame': 'Week 28 to Week 56', 'description': 'Percentage of participants with investigator-assessed flare-ups were reported.'}, {'measure': 'Periods 1, 2, and 3: Concentration of Total Activin A in Serum', 'timeFrame': 'Week 28, Week 56, Week 76', 'description': 'Concentration of total activin A in serum over time is reported.'}, {'measure': 'Periods 1, 2, and 3: Concentrations of Functional REGN2477 in Serum', 'timeFrame': 'Week 28, Week 56, Week 76', 'description': 'Concentrations of REGN2477 capable of target binding were measured (functional drug).'}, {'measure': 'Periods 1, 2, and 3: Number of Participants With Clinical Impact of Treatment-Emergent Anti-drug Antibodies (ADA) to REGN2477', 'timeFrame': 'Up to Week 76', 'description': 'Immunogenicity was characterized by ADA responses \\& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \\< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \\>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the REGN2477 ADA assay post first dose when baseline results = negative or missing.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibrodysplasia Ossificans Progressiva']}, 'referencesModule': {'references': [{'pmid': '39381032', 'type': 'DERIVED', 'citation': 'de Ruiter RD, Botman E, Teunissen BP, Lammertsma AA, Boellaard R, Raijmakers PG, Schwarte LA, Nieuwenhuijzen JA, Gonzalez Trotter D, Eekhoff EMW, Yaqub M. Performance of simplified methods for quantification of [18F]NaF uptake in fibrodysplasia ossificans progressiva. Front Nucl Med. 2024 Jul 22;4:1406947. doi: 10.3389/fnume.2024.1406947. eCollection 2024.'}, {'pmid': '37770652', 'type': 'DERIVED', 'citation': "Di Rocco M, Forleo-Neto E, Pignolo RJ, Keen R, Orcel P, Funck-Brentano T, Roux C, Kolta S, Madeo A, Bubbear JS, Tabarkiewicz J, Szczepanek M, Bachiller-Corral J, Cheung AM, Dahir KM, Botman E, Raijmakers PG, Al Mukaddam M, Tile L, Portal-Celhay C, Sarkar N, Hou P, Musser BJ, Boyapati A, Mohammadi K, Mellis SJ, Rankin AJ, Economides AN, Trotter DG, Herman GA, O'Meara SJ, DelGizzi R, Weinreich DM, Yancopoulos GD, Eekhoff EMW, Kaplan FS. Garetosmab in fibrodysplasia ossificans progressiva: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Med. 2023 Oct;29(10):2615-2624. doi: 10.1038/s41591-023-02561-8. Epub 2023 Sep 28."}, {'pmid': '32557665', 'type': 'DERIVED', 'citation': 'Vanhoutte F, Liang S, Ruddy M, Zhao A, Drewery T, Wang Y, DelGizzi R, Forleo-Neto E, Rajadhyaksha M, Herman G, Davis JD. Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study. J Clin Pharmacol. 2020 Nov;60(11):1424-1431. doi: 10.1002/jcph.1638. Epub 2020 Jun 18.'}, {'pmid': '32515349', 'type': 'DERIVED', 'citation': 'Aykul S, Corpina RA, Goebel EJ, Cunanan CJ, Dimitriou A, Kim HJ, Zhang Q, Rafique A, Leidich R, Wang X, McClain J, Jimenez J, Nannuru KC, Rothman NJ, Lees-Shepard JB, Martinez-Hackert E, Murphy AJ, Thompson TB, Economides AN, Idone V. Activin A forms a non-signaling complex with ACVR1 and type II Activin/BMP receptors via its finger 2 tip loop. Elife. 2020 Jun 9;9:e54582. doi: 10.7554/eLife.54582.'}]}, 'descriptionModule': {'briefSummary': 'This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3).\n\nPrimary safety objective of the study is to assess the safety and tolerability of REGN2477 in male and female patients with fibrodysplasia ossificans progressiva (FOP).\n\nPrimary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of HO lesions by computed tomography (CT).\n\nKey Secondary objectives are:\n\n* To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS) scores\n* To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as determined by the number of new HO lesions identified by 18F-NaF PET or by CT\n* To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET\n* To assess the effect of REGN2477, between week 28 and week 56, on the number, activity, and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from placebo to REGN2477 at week 28 versus the same patients between baseline and week 28\n* To assess the effect of REGN2477 versus placebo on the change from baseline in biochemical markers of bone formation\n* To characterize the concentrations of total activin A at baseline and over time following the first dose of study drug\n* To characterize the concentration-time profile (pharmacokinetics \\[PK\\]) of REGN2477 in patients with FOP\n* To assess the immunogenicity of REGN2477'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Men and women 18 to 60 years of age at screening.\n* Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive heterotopic ossification (HO)).\n* Confirmation of FOP diagnosis with documentation of any ACVR1 mutation.\n* FOP disease activity within 1 year of screening visit. FOP disease activity is defined as pain, swelling, stiffness, and other signs and symptoms associated with FOP flare-ups; or worsening of joint function, or radiographic progression of heterotopic ossifications (increase in site or number of HO lesions) with/without being associated with flare-up episodes.\n* Willing and able to undergo PET and CT imaging procedures and other procedures as defined in this study.\n\nKey Exclusion Criteria:\n\n* Significant concomitant illness or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease, that in the opinion of the study investigator might confound the results of the study or pose additional risk to the patient by their participation in the study.\n* Previous history or diagnosis of cancer.\n* Use of bisphosphonate within 1 year of screening.\n* Concurrent participation in another interventional clinical study, or a non-interventional study with radiographic measures or invasive procedures (e.g. collection of blood or tissue samples). Participation in the FOP Connection Registry or other studies in which participants complete study questionnaires are allowed.\n* Treatment with another investigational drug, denosumab, imatinib or isotretinoin in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer.\n* Pregnant or breastfeeding women.\n* Male and women of childbearing potential participants who are unwilling to practice highly effective contraception.\n\nNote: Other protocol defined Inclusion/Exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03188666', 'acronym': 'LUMINA-1', 'briefTitle': 'A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva', 'orgStudyIdInfo': {'id': 'R2477-FOP-1623'}, 'secondaryIdInfos': [{'id': '2016-005035-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REGN2477', 'interventionNames': ['Drug: REGN2477']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'REGN2477', 'type': 'DRUG', 'description': 'Pharmaceutical form: liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment periods 1 and 2.', 'armGroupLabels': ['REGN2477']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment period 1 only.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '751010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Lariboisiere,Hospitalier Universitaire Nord', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '16147', 'city': 'Genova', 'country': 'Italy', 'facility': 'Giannina Gaslini Institute', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '35-301', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Szpital Wojewodzki Nr 2', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'HA7 4LP', 'city': 'Stanmore', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital, Brockley Hill', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}