14. Tables, figures and graphs
Section 14 of a clinical study report holds the displays the text refers to but does not contain. Important displays stay in the text, and those that would be obtrusive there move to the end of it, with supporting displays and listings, cross-referenced from the text. Section 14 may hold summary figures and tables of demographic, efficacy and safety data; its safety part adds listings and narratives of deaths and other serious and significant adverse events, and a listing of abnormal laboratory values. Every display should identify the set of patients it was generated from.
What stays in the text and what moves to Section 14
E3 describes a report that places its tables and figures in the main text or at the end of it, and it heads Section 14 “Tables, figures and graphs referred to but not included in the text”.
E3 has a report present data at four levels of detail, and Section 14 holds the second:
| Level | Where it sits |
|---|---|
| Overall summary figures and tables for important demographic, efficacy and safety variables | The text of the report, where they may be placed to illustrate important points |
| Other summary figures, tables and listings for demographic, efficacy and safety variables | Section 14, where they should be provided |
| Individual participant data for specified groups of participants | Appendix 16.2, where they should be provided as listings |
| All individual participant data, as archival listings requested only in the US | Appendix 16.4, where they should be provided |
Important demographic, efficacy and safety data should be presented in summary figures or tables in the text of the report. If these displays become obtrusive because of their size or number, they should be presented in Section 14 instead, cross-referenced to the text, along with supportive or additional figures, tables or listings.
Figures should be used to summarise the important results visually, or to clarify results that are not easily understood from tables.
What Section 14 contains
E3 lists three parts that may be presented in Section 14, each as summary figures and tables.
- 14.1 Demographic data
- 14.2 Efficacy data
- 14.3 Safety data
Only the safety data part is divided further, into four subsections.
| Subsection | Contents |
|---|---|
| 14.3.1 | Displays of adverse events |
| 14.3.2 | Listings of deaths, other serious and significant adverse events |
| 14.3.3 | Narratives of deaths, other serious and certain other significant adverse events |
| 14.3.4 | Abnormal laboratory value listing, for each patient |
Identification of every display
E3 calls it particularly important that every analysis, table and figure clearly identifies, in the text or as part of the table, the set of patients from which it was generated.
An estimated or derived value used in any table, figure or data listing should be identified conspicuously, with a detailed explanation of how it was estimated or derived and what assumptions underlie it.
In the CORE Reference manual, every table and figure title includes the study or protocol number, and the title of a table or figure presenting results data also includes the subject population, so a table or figure copied and used outside the report's text always makes clear what it presents. The example study schematic that the manual recommends placing early in Section 9.1 carries the protocol number in its title in the same way.