Text and Data Mining valid from 2019-11-01
First Online: 1 November 2019
Compliance with Ethical Standards
: This study was supported by Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen was involved in all aspects of the study (design and conduct of the study; collection, management, analysis, and interpretation of data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication).
: Anja Geldhof, Jennifer Slater, Michael Clark, Urmila Chandran, and Danielle Coppola are employees of Janssen Research & Development or Janssen Biologics Division and may own company stock/stock options.
: The datasets generated during and/or analyzed during the current analysis are not publicly available because access to pharmacovigilance data must always be considered in respect to European Union laws, which protect the patient’s rights to personal privacy. However, upon reasonable request, the data may be made available by contacting the corresponding author.
: This observational analysis was based on pregnancy safety data extracted from a global safety database. Clinical trial registration and ethical approval were not required for this analysis. This article also does not contain any data from animals performed by any of the authors.
: Cumulative pregnancy safety data from a global safety surveillance database were summarized in this observational analysis. No identifying patient information was reported; therefore, no additional informed consent was required.