The body of the clinical study report (ICH E3 Section 12.2.2) should include a summary table of relatively common adverse events – those occurring in at least a particular percentage of subjects who received the investigational drug. This summary tabulation compares treatment and control groups and does not include subject identifying numbers or verbatim adverse event terms. Of note, the example table provided in Section 12.2.2 of the Guideline is not meant to be presented in Section 12.2.2 of the report, but in Section 14.3.2, which is not part of the text of the clinical study report.
The ICH E3 Guideline did not attempt to display all possible presentations of adverse event information, but rather outlined the summary table intended for Section 12.2.2 and provided an illustration of the far more detailed display that would be placed in Section 14.3.2. The example provided for Section 14.3.2, however, does not try to illustrate all possibilities, but shows individuals with adverse events by body system, severity, and perceived drug-relatedness, for treatment group “X.” Listings should also display investigator’s verbatim terms for each event and could be used to show demographic or disease-specific information, dosage, duration of treatment, or treatment cycle (for cancer chemotherapy).
Because it can be impractical to display all of this information in a single listing, such analyses can be presented in individual listings, e.g., by dose or other subgroup of interest. When adverse event data are presented by subgroup, however, a display of overall adverse events should also be included. For example, for a drug for subjects with chronic kidney disease, adverse events could be tabulated separately for subjects receiving or not receiving dialysis, but a table that includes adverse events in all subjects should also be included.
The listings that provide more comprehensive adverse event information, specifically subject identifiers and verbatim terms for each adverse event, should be provided in the study report, in Sections 14.3.1 and 16.2.7. If each adverse event is to be characterized extensively (i.e., many items in the listing), electronic approaches may be needed.