July 25 th 2014 Cenduit – new study drug discontinuation forms

2 New study drug discontinuation forms - Reasons | Presentation Title | Presenter Name | Date | Subject | Business Use Only  Old version Did not allow to distinguish the BKM120/placebo discontinuation from the fulvestrant discontinuation. Requested to discontinue the patient from the study in IRT even when the patient was still under Fulvestrant and was still in treatment phase.  New version Allow to stop Fulvestrant or BKM120/placebo first, and later the 2nd study drug. Allow to capture the real date of the treatment discontinuation and to match it with the reason of discontinuation -(so far when a patient was discontinued from BKM120/placebo but continued on fulvestrant, the patient had to be discontinued from IRT and the reason had to be other  not relevant, not matching reality)

3 New study drug discontinuation forms - features | Presentation Title | Presenter Name | Date | Subject | Business Use Only Old versionNew version BKM120/placebo discontinuation form  Select the date of the BKM/placebo discontinuation BKM120/placebo discontinuation form  Select the date of the BKM/placebo discontinuation  No further dispensing will be allowed in IRT  Select the reason of the discontinuation (even if Fulvestrant is still active) Fulvestrant discontinuation form  Select the date of the Fuvestrant discontinuation  BKM120/placebo can still be dispensed in IRT  No further dispensing will be allowed in IRT BKM120/placebo AND Fulvestrant discontinuation form  Select the date of the drug discontinuation  No further dispensing will be allowed in IRT  Select the reason of the discontinuation NOTE: If patient initially only discontinues BKM120/Placebo, later the form can be used to also discontinue Fulvestrant and vice versa. Then date and reason for discontinuation will have to be entered in the system when BOTH treatement will have been discontinued.

4 New forms - features | Presentation Title | Presenter Name | Date | Subject | Business Use Only  Select the best option which apply...

5 New forms - features | Presentation Title | Presenter Name | Date | Subject | Business Use Only  When selecting discontinue: BKM120/placebo or BKM120/placebo and Fulvestrant A warning message appears as the further dispensation of BKM120/placebo will no more be allowed in the system.  sites will have to confirm or revert back.

6 New forms - features | Presentation Title | Presenter Name | Date | Subject | Business Use Only  When selecting discontinue: BKM120/placebo or BKM120/placebo and Fulvestrant The warning message appears as well in the confirmation that the further dispensation of BKM120/placebo will no more be allowed in the system.

7 New forms - features | Presentation Title | Presenter Name | Date | Subject | Business Use Only  Confirmation is provided regarding which drug was stopped. It may be BKM120/placebo, Fulvestrant, or BOTH.  In case of mistake, please liaise as usual with the helpdesk to reverse the action.

8 Continued | Presentation Title | Presenter Name | Date | Subject | Business Use Only  Once BOTH study drug are discontinued (at once or in sequential order), select the discontinuation form to record the reason of the discontiuation: Progressive disease Death Other (for Adverse Event, protocol deviation, subject decision to stop study drug, etc.)