| Outcome Measures: |
Primary: Number of adverse events of special interests (AESI), Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies, Throughout the study, approximately 10 years|Number of serious adverse events (SAE), Throughout the study, approximately 10 years|Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy, From start of pregnancy to 12 months post-partum|Number of maternal pregnancy-related events, From start of pregnancy to 12 months post-partum|Developmental outcomes of the infant, From birth of infant to 12 months |
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| Locations: |
University of Chicago Medical Center- Site Number : 8400017, Chicago, Illinois, 60637, United States|Riley Hospital for Children at IU Health- Site Number : 8400004, Indianapolis, Indiana, 46202, United States|Norton Healthcare- Site Number : 8400030, Louisville, Kentucky, 40202, United States|Johns Hopkins School of Medicine- Site Number : 8400031, Baltimore, Maryland, 21205, United States|University of Michigan Health System - Ann Arbor- Site Number : 8400028, Ann Arbor, Michigan, 48109, United States|Corewell Health- Site Number : 8400009, Grand Rapids, Michigan, 49503, United States|Mayo Clinic- Site Number : 8400010, Rochester, Minnesota, 55902, United States|Children's Mercy Adelle Hall Campus- Site Number : 8400014, Kansas City, Missouri, 64108, United States|Women and Children's Hospital of Buffalo- Site Number : 8400018, Buffalo, New York, 14222, United States|Ten's Medical PC- Site Number : 8400027, Staten Island, New York, 10306, United States|~SUNY Upstate Medical University- Site Number : 8400007, Syracuse, New York, 13210, United States|University of North Carolina at Chapel Hill- Site Number : 8400008, Chapel Hill, North Carolina, 27514, United States|Cincinnati Children's Hospital Medical Center- Site Number : 8400024, Cincinnati, Ohio, 45229, United States|Columbus Regional Healthcare- Site Number : 8400013, Columbus, Ohio, 31901, United States|The Ohio State University- Site Number : 8400032, Columbus, Ohio, 43210, United States|Hospital of The University of Pennsylvania- Site Number : 8400021, Philadelphia, Pennsylvania, 19104, United States|The Children's Hospital of Philadelphia- Site Number : 8400029, Philadelphia, Pennsylvania, 19104, United States|AM Diabetes & Endocrinology Center- Site Number : 8400012, Bartlett, Tennessee, 38133, United States|Vanderbilt University Medical Center- Site Number : 8400023, Nashville, Tennessee, 37232, United States|University of Texas - Southwestern Medical Center- Site Number : 8400003, Dallas, Texas, 75390, United States|Texas Children's Hospital- Site Number : 8400002, Houston, Texas, 77030, United States|University of Utah Health Care- Site Number : 8400019, Salt Lake City, Utah, 84132-0001, United States
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