Table 1.
Obligatory and voluntary items on the adverse drug reaction (ADR) report
| Obligatory | Voluntary |
| Patient details | |
| Patient initials* | Week of pregnancy |
| Date of birth* | Breastfeeding? (yes/no) |
| Gender* | Profession |
| Height* | |
| Weight* | |
| Drug | |
| Name of drug* | If used previously, was the drug tolerated at the time? |
| Prescribed for* | Was the drug continued or read ministered after onset of ADR? |
| Date drug started | |
| Date drug stopped | |
| Suspected of causing ADR (yes/no/unsure) | |
| Dosage | |
| Diagnosis | |
| Name* | Type of diagnose (primary, concomitant, secondary) |
| ICD-10 code* | Diagnosis confirmed on date |
| ADR | |
| Symptom | Initial worsening of symptom |
| Severity according to WHO-ART | |
| Serious or non-serious according to ICH | If serious, why? |
| Date ADR started | |
| Date ADR stopped | |
| Treatment of ADR completed? (yes/no) | Reason for not completing treatment of ADR |
| Causality | |
* Imported electronically from the computerized patient documentation system into QuaDoSta