![36image0.png](36image0.png) irb protocol
20.0 appendices

Appendix 1: Everolimus (RAD001) Continuous Cycle Schedule Treatment Log (5mg every other day)  
IRB
IRB\#: 10-165A(1)  
| Patient Name:   | Patient MRN:   |
|-----------------|----------------|
| Protocol 10-165: Phase I/II Study of Everolimus and Intravesical Gemcitabine in BCGRefractory Primary or Secondary Carcinoma In Situ of the Bladder EVEROLIMUS (RAD001) CONTINUOUS CYCLE SCHEDULE TREATMENT LOG Place a check in the box next to the date you take this medication.  Please bring this sheet to your study doctor's office on each visit Cycle:  Date Day Time Treatment Dose Questions for Study Doctor/Nurse Everolimus  5 mg 1 2 Everolimus   3 4 Everolimus  5 6 Everolimus  7 8 Everolimus  9 10 Everolimus   11 12 Everolimus  13 14 Everolimus  15 16 Everolimus  17 18 Everolimus   19 20                 |                |  
  
IRB PROTOCOL
IRB\#: 10-165A(1)  
| IRB#: 10-165A(1)   |              |                     |
|--------------------|--------------|---------------------|
| Everolimus        |              |                     |
| 21 22              | Everolimus  |                     |
| 23 24              | Everolimus  |                     |
| 25 26              | Everolimus  |                     |
| 27 28              |              |                     |
| MD/RN Signature:   | Date:        | Tablets Remaining:_ |  
  
Comments:_  
| Patient Name   | Patient MRN:   |
|----------------|----------------|
| Protocol 10-165: Phase I/II Study of Everolimus and Intravesical Gemcitabine in BCGRefractory Primary or Secondary Carcinoma In Situ of the Bladder EVEROLIMUS (RAD001) CONTINUOUS CYCLE SCHEDULE TREATMENT LOG Place a check in the box next to the date you take this medication.  Please bring this sheet to your study doctor's office on each visit Cycle:  Date Day Time Treatment Dose Questions for Study Doctor/Nurse Everolimus  5 mg 1 Everolimus   2 Everolimus   3 Everolimus   4 Everolimus   5 Everolimus   6 Everolimus   7                |                |  
Appendix 2: Everolimus (RAD001) Continuous Cycle Schedule Treatment Log (5 mg every day)  
| IRB PROTOCOL     | IRB#: 10-165A(1)   |                   |
|------------------|--------------------|-------------------|
| Everolimus      |                    |                   |
| 8                | Everolimus        |                   |
| 9                | Everolimus        |                   |
| 10               | Everolimus        |                   |
| 11               | Everolimus        |                   |
| 12               | Everolimus        |                   |
| 13               | Everolimus        |                   |
| 14               | Everolimus        |                   |
| 15               | Everolimus        |                   |
| 16               | Everolimus        |                   |
| 17               | Everolimus        |                   |
| 18               | Everolimus        |                   |
| 19               | Everolimus        |                   |
| 20               | Everolimus        |                   |
| 21               | Everolimus        |                   |
| 22               | Everolimus        |                   |
| 23               | Everolimus        |                   |
| 24               | Everolimus        |                   |
| 25               | Everolimus        |                   |
| 26               | Everolimus        |                   |
| 27               | Everolimus        |                   |
| 28               |                    |                   |
| MD/RN Signature: | Date_              | Tablets Remaining |
| Comments:_       |                    |                   |  
  
Appendix 3: Everolimus (RAD001) Continuous Cycle Schedule Treatment Log (10 mg every day)  
  
  
IRB PROTOCOL
IRB\#: 10-165A(1)
Patient Name: Patient MRN:  
| Patient Name:   | Patient MRN:   |
|-----------------|----------------|
| Protocol 10-165: Phase I/II Study of Everolimus and Intravesical Gemcitabine in BCGRefractory Primary or Secondary Carcinoma In Situ of the Bladder EVEROLIMUS (RAD001) CONTINUOUS CYCLE SCHEDULE TREATMENT LOG Place a check in the box next to the date you take this  medication. Please bring this sheet to your study  doctor's office on each visit Cycle:  Date Day Time Treatment Dose Questions for Study Doctor/Nurse Everolimus  10 mg 1 Everolimus   2 Everolimus   3 Everolimus   4 Everolimus   5 Everolimus   6 Everolimus   7 Everolimus   8 Everolimus   9 Everolimus   10 Everolimus   11 Everolimus   12 Everolimus   13 Everolimus   14 Everolimus   15 Everolimus   16 Everolimus   17 Everolimus   18 Everolimus   19 Everolimus   20 Amended: 1/11/11                 |                |  
| IRB PROTOCOL   | IRB#: 10-165A(1)   |           |
|----------------|--------------------|-----------|
| Everolimus    |                    |           |
| 21             | Everolimus        |           |
| 22             | Everolimus        |           |
| 23             | Everolimus        |           |
| 24             | Everolimus        |           |
| 25             | Everolimus        |           |
| 26             | Everolimus        |           |
| 27             | Everolimus        |           |
| 28             |                    |           |
| MD/RN          | Tablets            |           |
| Signature:     | Date_              | Remaining |
| Comments:_     |                    |           |