• post-marketing su
  • This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF. (clinicaltrials.gov)
  • Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form. (clinicaltrials.gov)
  • Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. (clinicaltrials.gov)
  • At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. (clinicaltrials.gov)
  • Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. (clinicaltrials.gov)