SDTM: AE vs CE - basic examples for difference between adverse event and clinical event

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  • Опубликовано: 3 дек 2024

Комментарии • 13

  • @kbhavya8829
    @kbhavya8829 Год назад +1

    Thanks for sharing knowledge, Please upload SE,SV Domains

    • @mycsg
      @mycsg  Год назад

      Sure Bhavya.. will try to create soon..

  • @sivasankar.parasa1029
    @sivasankar.parasa1029 Год назад

    Congratulations!
    Thank you for your efforts, please briefly explain those domains AG & ML...

    • @mycsg
      @mycsg  Год назад

      Thank you Sivasankar. I will try to cover them in future videos.

  • @sadaiahnarakatla1218
    @sadaiahnarakatla1218 Год назад

    Thanks for sharing your knowledge, please do the video difference b/w EX and EC?

    • @mycsg
      @mycsg  Год назад

      Hi Sadiah, we already have a video on the requested topic.
      ruclips.net/video/LcUVCw5KTOA/видео.html

  • @tomciya2295
    @tomciya2295 Год назад

    Hi sir, will you please explain association between BS AND BE , AE and FA domain

    • @mycsg
      @mycsg  Год назад +1

      Hi Tomciya, sure I will try to cover these in future videos. Meanwhile, for your query related to FA.
      Findings about domain is used to collect additional information about an event or intervention.
      Example 1:
      In a study evaluating a new treatment for anemia, anemia history is captured as part of medical history. Medical history domain structure restricts the collection of additional information about anemia apart from the start date, end date, severity etc. Additional information about symptoms of anemic history like shortness of breath, fatigue can be collected in Findings About domain.
      Example 2:
      In a study related to Chronic Kidney Disease (CKD), information related to start date of CKD is collected as part of medical history. However additional follow-up questions about this medical history (event) like the cause of CKD (diabetic nephropathy, hypertensive nephropathy etc), and stage of CKD do not fit in medical history, so this information is collected as part of FA domain.

  • @VenkatVenkat-qm6sw
    @VenkatVenkat-qm6sw 4 месяца назад

    What is difference between solicited and unsolicited adverse events with respect to vaccines trial?

    • @mycsg
      @mycsg  4 месяца назад +1

      with some vaccines, symptoms like fever and body pains are expected, such expected symptoms are considered as soloicited... similarly for injection based vaccines , pain, redness at the site of injection are expected.. those are also considered solicited...
      all other events which are not considered solicited in the protocol are considered unsolicited...

    • @VenkatVenkat-qm6sw
      @VenkatVenkat-qm6sw 4 месяца назад

      @@mycsg Thanks a lot

  • @sadaiahnarakatla1218
    @sadaiahnarakatla1218 Год назад

    Difference between ADEX and ADEXSUM? if it is possible make a video.

    • @mycsg
      @mycsg  Год назад

      Hi Sadaiah, sure. It may take some time but will definitely do a video on this.