PATIENT INFORMATION Patient’s initials (only state the first letter in the first name and surname and not the full name) * : Gender * : Male Female Pregnant? * Yes No Age at the time of the side effect * : Weight * : Are you the patient? Yes – I am the patient No – I am reporting on behalf of someone else DRUG INFORMATION Name of LEO Pharma drug used * : Lot/batch no. of LEO Pharma drug Name of the condition for which this LEO Pharma drug was used * : First date of treatment with the LEO Pharma drug * : Daily dose of the LEO Pharma drug * : Has treatment with the LEO Pharma drug been stopped? * Yes No If yes, on which date did the treatment stop? SIDE EFFECT INFORMATION Which side effect(s) did the patient experience? * At what date were the side effect(s) first noticed? * Describe what happened (how did the side effect(s) start, how did they develop, did the patient seek advice or treatment from a healthcare professional, and how were the side effect(s) treated?) * : Has the patient suffered from the same side effect(s) previously? * Yes No If yes, please specify which drug(s) were taken at the time: How are the side effect(s) right now? * Recovered Recovering They are still ongoing I do not know Did the side effect(s) following use of the LEO Pharma drug lead to any of the following? * Admittance to hospital Prolongation of an existing hospitalization Permanent disability or incapacity that affects daily life and that is not going to improve further Birth defect Life-threatening situation Death of the patient None of the above If the side effect(s) following use of the LEO Pharma drug led to death, please specify the date the patient died. If this does not apply, please leave blank. OTHER DRUG INFORMATION Were other drugs taken at the same time as the one where the side effect(s) occurred? * Yes No If yes, please list the following information: a) The name of the drug(s): b) The disease(s) for which the drug(s) were taken: c) The start date: DISEASE INFORMATION At the time of the side effect(s) to the LEO Pharma drug, was the patient suffering from any other disease, including allergies? * Yes No If yes, please describe the following: a) Disease: b) Date started: c) Treatment prescribed: ADDITIONAL INFORMATION Please use this field for further relevant information: REPORTER INFORMATION Your name * : Country * : Are you a healthcare professional? * Yes No If yes, please specify type: Email address (a copy of the form will be sent to this email) * : Do you agree to be contacted again for further information, if necessary? * Yes No Please press the “send” button in order for LEO Pharma to receive your side effect report.
