NSABP PROTOCOL R-04: FORM ALERT Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder:


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January 9, 2015

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Colorectal Cancer NCT00058474 Toxicity - NSABP PROTOCOL R-04: FORM ALERT - 2082606v3.0

*Unexpected: AE not listed in drug package insert (5FU and Epoetin alfa) or in the Investigator's Brochure (Capecitabine).

Ccrr Module For Nsabp Protocol R-04: Form Alert
Are data amended?
Notify Local IRB?
Was the patient hospitalized for 24 hours or more?
CTC Adverse Event Type
Protocol Therapy
CTC Adverse Event Attribution Code

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