Table 3.
Variables in individual patient listings for adverse events, and in narratives
| Variables | ICH E3 specified variables for IP AE listing* | Variables in DLX CSR IP AE listing | ICH E3 specified variables for narrative* | Variables in DLX CSR narratives |
| Investigator | Yes | Yes | — | — |
| Treatment group | Yes | Yes | Yes | |
| Patient identifier | Yes | Yes | Yes | Yes |
| Age, race, sex, weight | Yes | — | Yes | Yes |
| Location of CRFs, if provided | Yes | — | — | — |
| The adverse event (preferred term, reported term) | Yes | Reported term only | — | Yes (preferred and reported terms) |
| Duration of adverse event | Yes | Yes* | — | Yes |
| Severity | Yes | Yes | — | Only for adverse events that led to discontinuation |
| Seriousness (serious/non-serious) | Yes | Yes | — | Yes |
| Action taken (none, dose reduced, treatment stopped, specific treatment instituted, etc) | Yes | — | — | Yes† |
| Outcome (for example, CIOMS format) | Yes | Start and stop dates of event provided | — | Yes* |
| Causality assessment (for example, related/not related) | Yes | Yes | Yes | Yes |
| Date of onset or date of clinic visit at which event was discovered | Yes | Yes | — | Yes |
| Timing of onset of adverse event in relation to last dose of test drug/investigational product (when applicable) | Yes | Yes | — | Yes |
| Study treatment at time of event or most recent study treatment taken | Yes | — | — | Yes |
| Test drug/investigational product dose in absolute amount, mg/kg or mg/m² at time of event | Yes | — | — | Yes |
| Drug concentration (if known) | Yes | — | — | — |
| Duration of test drug/investigational product treatment | Yes | — | — | Yes |
| Concomitant treatment during study | Yes | — | — | Yes |
| Date study drug started | — | Yes | Yes | Yes |
| Relevant concomitant/previous illnesses with details of occurrence/duration | — | Yes | Yes | Yes |
| Relevant concomitant/previous drug with details of dosage | — | — | Yes | Yes |
| Relevant laboratory measurements | — | — | Yes | Yes |
CIOMS=Council for International Organizations of Medical Sciences guidelines; CRF=case report form; CSR=clinical study report; DLX=duloxetine; ICH E3=International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use: structure and content of clincal study reports: E3; IP AE=individual patient adverse event.
*Can be calculated from information in data format.
†Apparent from information in text.