9. Tamiflu IV CU 056_End Of Treatment Case Report Form

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COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) CU 056 Preceding and Concomitant Medications Antiviral Medications Received by Patient prior to Receiving Oseltamivir IV Name of Medication Dose Frequency e.g BID, TID Route e.g. oral, IV Date Commenced DD/MM/YY Date Stopped DD/MM/YY Concomitant Medications Received by Patient while Receiving Oseltamivir IV Name of Medication Dose Frequency e.g BID, TID Route e.g. oral, IV Date Commenced DD/MM/YY Date Stopped DD/MM/YY Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) – End of Treatment - Version 5 February 2010 2/3
COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) Influenza Details Date of onset of influenza symptoms (DDMMYY): Laboratory confirmation of influenza (if available): |__|__||__|__||__|__| No Yes If yes, please specify any laboratory findings including viral loads and details of any virologically confirmed resistance: ________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ Outcome of Influenza Illness and Complications 1 Recovered / Resolved - i.e. discharged from hospital Date:..DD____MM____YY_____ 2 Not recovered/not resolved - i.e. remains in hospital Date:..DD____MM____YY_____ 3 Death - complete the adverse events collection form Date:..DD____MM____YY_____ Premature Discontinuation of Intravenous Treatment Primary reason for premature treatment discontinuation: Switch to oral Tamiflu Patient declined further treatment Adverse event – please complete the “adverse Events notification form” Treatment failure = lack of anticipated antiviral effect by physician - please complete the “adverse Events notification form” Diagnosis of influenza excluded Pregnancy – please complete the “pregnancy report form”( discontinuation / risk assessment) Death – the direct cause of death must be reported as SAE via AE form Other reason (please specify):_____________________________________________________ Unused Tamiflu IV medication Please return any unused medication to NV Roche SA to the attention of Albert de Roose - Rue Dantestraat 75 – 1070 Brussels (tel +32 2 525 82 11). Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) – End of Treatment - Version 5 February 2010 3/3
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9. Tamiflu IV CU 056_End Of Treatment Case Report Form

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