Hi Query 1 for subjects counts in the above summary table, why Aedecod is not consider as subject is counted only once at particuler AE? Query 2 in above summary table if 1st column contain only 3 rows as Mild, Modrate, Severe and Footnote is given as Subject is counted only once at perticuler AE at highest severity then in such case do we exhicute the same way without considering AEDECOD as you explain? Query 3 If we have Summary Table as Summary of TEAE by Soc, Pt, severity and under Treatment columns we have format as n (%) [E] and have footnote as Subject is counted only once at perticuler AE at highest severity then in such case we have to consider AEDECOD and count the distinct subject at maximum severity across AEDECOD. but how the [E] will be estimated as 1) All or 2) Only respective Maximum Severity Events or 3) Only Distinct Maximum Severity Events ?? kindly explain above queries? Thank you.
Response to query 1: As this an overview table, we need to count a subject only once per the criteria required on a row irrespective of the number of events experienced by the subject which meet that row's filter condition. If we include AEDECOD in the by group when fetching the counts, we will get number of subjects with each event, which is not needed here. Response to query 2: In an overview table, if we have segregation at Mild, Moderate and Severe level, we need to fetch the maximum severity seen within each subject, but not the maximum within each aedecod. So, we should not use AEDECOD here. Response to query 3: presenting m count on maximum severity tables is always ambiguous, as you mentioned all three are possible. There is no standard answer to this question. It depends on what your reviewer wants. My personal preference would be option 2 - 'Only respective Maximum Severity Events '.
Hi
Query 1
for subjects counts in the above summary table,
why Aedecod is not consider as subject is counted only once at particuler AE?
Query 2
in above summary table if 1st column contain only 3 rows as Mild, Modrate, Severe and Footnote is given as Subject is counted only once at perticuler AE at highest severity then in such case do we exhicute the same way without considering AEDECOD as you explain?
Query 3
If we have Summary Table as Summary of TEAE by Soc, Pt, severity and under Treatment columns we have format as n (%) [E] and have footnote as Subject is counted only once at perticuler AE at highest severity then in such case we have to consider AEDECOD and count the distinct subject at maximum severity across AEDECOD. but how the [E] will be estimated as
1) All
or
2) Only respective Maximum Severity Events
or
3) Only Distinct Maximum Severity Events ??
kindly explain above queries?
Thank you.
Response to query 1:
As this an overview table, we need to count a subject only once per the criteria required on a row irrespective of the number of events experienced by the subject which meet that row's filter condition. If we include AEDECOD in the by group when fetching the counts, we will get number of subjects with each event, which is not needed here.
Response to query 2:
In an overview table, if we have segregation at Mild, Moderate and Severe level, we need to fetch the maximum severity seen within each subject, but not the maximum within each aedecod. So, we should not use AEDECOD here.
Response to query 3:
presenting m count on maximum severity tables is always ambiguous, as you mentioned all three are possible. There is no standard answer to this question. It depends on what your reviewer wants. My personal preference would be option 2 - 'Only respective Maximum Severity Events '.
Thanks a lot for timely reply and for kind concern
Hi can you explain how to derive TEAE casually related to study treatment and TEAE casually related to study procedure
Hi Prasanth, we do not derive the 'casually related to study treatment' information. It will be reported by the investigator on the crf page.