What is criteria for adverse events and treatment-emergent adverse events?

What is criteria for adverse events and treatment-emergent
adverse events?

Question Posted / hari prasad

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What is criteria for adverse events and treatment-emergent adverse events?..

Answer / nsb

Adverse Event (AE):
Any unwanted medical occurrence after the treatment
with the study drug.

Treatment Emergent Adverse Event (TEAE):
Any adverse event which occurred or worsened in
severity after the treatment with the study drug.

Is This Answer Correct ?

11 Yes

5 No

What is criteria for adverse events and treatment-emergent adverse events?..

Answer / dexter

for adverse event aeid is ne missing and for treatment
emergent adverse event treatment emergent flag is set.or
directly in ADS we can state Any AE that worsens in severity
as compared to the baseline then that event becomes
treatment emergent adverse event. Also, if a new event
occurs in the post baseline period then also it is
classified as the treatment emergent adverse event.

Is This Answer Correct ?

7 Yes

3 No

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