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Re: CaptainObvious post# 110520

Wednesday, 03/29/2017 3:55:19 PM

Wednesday, March 29, 2017 3:55:19 PM

Post# of 694201
I got this from message 124555547. Sunday must have had an End of Treatment visit and will be followed for survival.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124555547

Treatment Discontinuation Due to no Study Drug Availability:
• If the crossover patient is receiving DCVax-L and no more study drug is
available, the patient will discontinue from active treatment, have an End of
Treatment (EOT) visit, Section 8.5, and will be followed for survival. Follow-up
will be conducted through quarterly phone calls per Sections 11 and 14.5 of the
protocol.
• An explanation for discontinuing treatment is recorded for each patient on the
appropriate eCRF.
8.5. END OF TREATMENT (EOT) VISIT SCHEDULE AND PROCEDURES (ALL
PATIENTS – RANDOMIZED AND CROSSOVER):
• EOT Visits for all patients who discontinue from the study should occur at least 7
days, but ≤ 30 days, after the last immunization and prior to beginning other
treatment. Procedures to be performed during the EOT Visit include:
• Physical Exam
• Neurological Exam
• Vital Signs
• KPS
• MRI of brain
• CBC and Differential
• Blood Chemistry - Comprehensive metabolic panel, including electrolyte balance,
and hepatic and renal functions
• Serum markers of Autoimmune disease (anti-DNA)
• Urinalysis
• AE Assessment
• Concomitant Medication
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