S1011 Adverse Event Form (#10184) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer Source Form: NCI FormBuilder:


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  1. 26.08.12
  2. 08.01.15
  3. 09.01.15
  4. 09.01.15
Hochgeladen am:

9. Januar 2015

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Bladder Cancer NCT01224665 Toxicity - S1011 Adverse Event Form (#10184) - 3244012v1.0

Instructions: Please complete this form within 7 days of hospital discharge, and also at 90 days post surgery. For first reporting period record all adverse events up until hospital discharge. For second reporting period record all events after hospital discharge and up until 90 days post surgery. Report all adverse events observed. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Indicate if the adverse event results in inpatient hospitalization or prolongation of existing hospitalization for 24 hours. Follow instructions in Section 16.0 of the protocol for expedited reporting requirements on this study. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form.

Adverse Events