HCP Summary Tabulation Columns
Table 7-4 HCP Summary Tabulation Columns
| SI | Temp table reference |
|---|---|
|
Preferred Term |
LLT or PT is printed based on the report parameter Print LLT instead of PT. System prints diagnosis if the report parameter Use Only Diagnosis Events is Y. If this parameter is N, then diagnosis as well as symptoms are printed. LLT or PT is arranged in alphabetical order within a SOC. |
|
Solicited |
Solicited cases are clinical trial cases having at least one event related to the drug. Either the company or reporter causality flag is Y. |
|
Serious-Sponsored |
The count of Serious Events with report type group as Sponsored Study, and case type text as Solicited is printed in this column. |
|
Serious-Non-Sponsored |
The count of Serious Events with report type group as Non-Sponsored Study, and case type text as Solicited is printed in this column. |
|
Sub-total |
The sub-total is computed by summing-up Serious sponsored and unsponsored events from Solicited cases. |
|
Non-Solicited |
Non-Solicited cases are Non-Clinical trial cases having at least one event related to the drug. Either the company or reporter causality flag is Y. |
|
Serious-Direct to MAH |
The count of Serious Events with report type group as Direct to MAH, and case type text as Non-solicited is printed in this column. |
|
Serious-HA |
The count of Serious Events with report type group as HA, and case type text as Non-solicited is printed in this column. |
|
Serious-Stimulated |
The count of Serious Events with report type group as Stimulated, and case type text as Non-solicited is printed in this column. |
|
Serious-Literature |
The count of Serious Events with report type group as Literature, and case type text as Non-solicited is printed in this column. |
|
Sub-total |
The sub-total is computed by summing-up Serious events from Non-Solicited cases. |
|
Non-Serious -Direct to MAH |
The count of Non-Serious Events with report type group as Direct to MAH, and case type text as Non-solicited is printed in this column. |
|
Non-Serious-HA |
The count of Non-Serious Events with report type group as HA, and case type text as Non-solicited is printed in this column. |
|
Non-Serious-Stimulated |
The count of Non-Serious Events with report type group as Stimulated, and case type text as Non-solicited is printed in this column. |
|
Non-Serious-Literature |
The count of Non-Serious Events with report type group as Literature, and case type text as Non-solicited is printed in this column. |
|
Sub-total |
The sub-total is computed by summing-up Non-Serious events from Non-Solicited cases. |
|
Total |
The total is computed by summing-up the sub-totals of Solicited and Non-solicited columns. |
|
Total events for <SOC> |
The count of Events is printed against respective column at the end of SOC grouping. |
|
Total events for <Drug> |
The count of Events is printed against respective column at the end of Drug grouping. |
|
Total of distinct cases for <Drug> |
The count of Distinct Cases is printed against respective column at the end of Drug grouping. |
For more information, see: