REPORT CURRENT AS of (Date):DATE of LAST REGULARLY SCHEDULEDDSMC REVIEW

REPORT CURRENT AS OF (date):DATE OF LAST REGULARLY SCHEDULEDDSMC REVIEW:

SECTION I: BASIC PROTOCOL DATA

IRB#:PI:

TITLE:

Study coordinator/contact:Phone: Email:

Name of person responsible for report:Phone: Email:

SECTION II: PROTOCOL STATUS

Study open to accrual

Study on hold

Date study placed on hold Reason study was placed on hold

Study closed to accrual, but subjects remain on study related treatment

Date study closed to accrual Reason study closed to accrual

Study closed to accrual, no further subjects undergoing study related treatment(Final Report)

Date last subject received study related treatment

NOTE: The previous definitions of “Affiliate” and “Participating” sites are no longer valid. All sites other than UNMC/NMC and their associated locations are now considered “Participating” sites. This includes Children’s Hospital and Medical Center.

ALSO NOTE: UNMC/NMC associated locations include but are not limited to the Bellevue Medical Center, Village Pointe Medical Center, NE Orthopedic Hospital, and UNMC/NMC Clinics. This does not include Children’s Hospital and Medical Center.

SECTION III: ACCRUAL – SINCE LAST REGULARLY SCHEDULEDREVIEW and OVERALL

A. Total# of new patients enrolled at UNMCand Associated Locations since last regularly scheduledDSMC review:

B.Total # of subjects enrolled at UNMCand Associated Locationssince study activation

SECTION IV: TOTAL ENROLLED, WITHDRAWN and INELIGIBLE

Provide the following information for UNMC and Associated Locations:

Total # withdrawn without receiving treatment / Total # found to be ineligible for protocol

SECTIONV: FOR MULTI PHASE STUDIES ONLY

A. Current enrollment to each phase of this protocol:

Phase / Date last subject was enrolled
to this phase of the protocol / Total # of subjects enrolled to this phase
at UNMC and Associated Locations

SECTION VI: INTERIM ANALYSIS AND STOPPING RULES

1. Does this protocol contain an interim analysis? Yes No If yes, you must answer 1a and 1b.

1. Provide details as outlined in the protocol:
2. What is the estimated time frame the interim analysis will be completed?

1. Does this protocol contain a stopping rule for safety? Yes No
2. If yes, provide details as outlined in the protocol:
3. Does this protocol contain a stopping rule for efficacy? Yes No
4. If yes, provide details as outlined in the protocol:

SECTION VII: DOSE LEVEL(S) STUDIED

Provide the following information separately for each dose level studied:

Dose Level / Dose and Schedule
of Agents / Total # entered at this dose/schedule / Total # withdrawn without receiving treatment / Total # found to be ineligible for protocol

SECTION VII: ADVERSE EVENT REPORTING WORKSHEET

Complete and attach an Adverse Event Reporting Worksheet, listing all reportable adverse events at UNMC and Associated Locationsas detailed in Section 9.0 of the protocol document.

Worksheet must include:

1. The subject’s UNMC Medical Record Number or unique protocol identification number (if no UNMC MR# is available)
2. The Site where the subject was enrolled (a unique site identifier may be used as long as a legend for these identifiers is included at the bottom of the worksheet)
3. A Description of the type of adverse/serious adverse event (AE/SAE). Please utilize please use consistent terms in describing the AE’s for conformity and to make tracking the AE frequencies more transparent.
4. Use an asterisk (*) at the beginning of each descriptionto mark any events that were not reported on previous Adverse Event Reporting Worksheets
5. The Date of the AE/SAE
6. The Grade of the AE/SAE (see current CTC for definitions)
7. The Attribution of the AE/SAE (unlikely, possibly, probably or definitely related to treatment)
8. For all AE/SAE's that were not reported on previous Adverse Event Reporting Worksheets, an indication of whether the AE/SAE was Serious Or Not Serious

IMPORTANT NOTE: Any changes to events previously listed on the DSMC Worksheet should be made by crossing out the previous entry and adding the new or updated information.

______

Signature of Principal Investigator Date

Fred & Pamela Buffett Cancer Center Page 1 of 3

DSMC Report for Phase 1 Studies Being Conducted Only at UNMC and Associated Locations (07/08/16)