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

COMPASSIONATE USE – CU 056
Intravenous TAMIFLU ® (oseltamivir)
Tamiflu IV End of Treatment Form
Data collection form at the end / discontinuation of treatment
PLEASE COMPLETE IN BLOCK CAPITAL LETTERS
Please send this completed form by fax (+32 2 558 93 72) to
NV ROCHE SA – Rue Dantestraat 75 – 1070 Brussels (tel +32 2 525 82 11)
Physician
Name: ………………………………...
Hospital/Clinic: …………………………..
Signature: …………………………………….
Date (DDMMYY): |__|__||__|__||__|__|
Patient details
Initials of the patient: |__|__| |__|__| Sex: M F Height: |__|__|__| cm
Date of birth (DDMMYY): |__|__||__|__||__|__|
Weight: |__|__|__| kg
Please specify any important underlying diseases / conditions:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
Ventilation support No Yes If YES: Number of days ventilated: |__|__|
Tamiflu IV dosing
Dose / infusion (mg): |__|__|__| Frequency / day: |__|__| Treatment duration (days): |__|__|
Adverse Event (AE)
Did the patient experience an adverse event during the treatment Yes No
If YES, please fill in an AE form if not yet done.
Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) – End of Treatment - Version 5 February 2010
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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
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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
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