What is criteria for adverse events and treatment-emergent
adverse events?
Answers were Sorted based on User's Feedback
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 |
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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Hello, I have PROC SQLs results group by 3 fields and I use SUM and COUNT functions in SQL. The problem is when I try to display my result with PROC TABULATE. I am getting very big numbers. I believe I make a mistake some where in Tabulate. Here is my Proc Tabulate. PROC TABULATE DATA=OUT04_05 FORMAT=12.; CLASS YR CENTRE VISA / PRELOADFMT EXCLUSIVE; VAR NEWUSER FRAUD TRANSFER AUTUSER REISSUE; TABLE CENTRE ALL, (YR ALL)*VISA, (NEWUSER*F=COMMA12. AUTUSER*F=COMMA12. FRAUD*F=COMMA12. TRANSFER*F=COMMA12. REISSUE*F=COMMA12.) / MISSTEXT={LABEL='0'} PRINTMISS RTS=20; FORMAT VISA VISAFMT.; KEYLABEL SUM = ' ' ALL = 'TOTAL'; LABEL YR = 'DATE YEAR' NEWUSER = 'TOTAL NEW ACCT' TRANSFER = 'TOTAL TRANSFER' FRAUD = 'TOTAL FRAUD TRANSFER' AUTUSER = 'TOTAL AUTH USERS' REISSUE = 'TOTAL REISSUE'; When I code it like : NEWUSER*N*F=COMMA12. AUTUSER*N*F=COMMA12. I get same amount numbers but to find a NEWUSER I use COUNT(*) and to find AUTUSER I use SUM(xxxx) function so both result shouldn’t be the same my problem is in this point. Could you tell me where the problem in code is. How can I display my result? TX.
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