untitled h1
appendix a performance status criteria

| ECOG Performance Status Scale                                                                              | Karnofsky Performance Scale                                                             |                                                                                 |                                                            |                                       |             |       |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------|-------------|-------|
| Grade                                                                                                      | Descriptions                                                                            | Percent                                                                         | Description                                                |                                       |             |       |
| 100                                                                                                        | Normal, no complaints, no evidence                                                      |                                                                                 |                                                            |                                       |             |       |
| Normal activity. Fully active, able                                                                        | of disease.                                                                             |                                                                                 |                                                            |                                       |             |       |
| 0                                                                                                          | to                                                                                      | carry                                                                           | on                                                         | all                                   | pre-disease |       |
| performance without restriction.                                                                           | 90                                                                                      | Able to carry on normal activity;  minor signs or symptoms of disease.          |                                                            |                                       |             |       |
| Symptoms,                                                                                                  | but                                                                                     | ambulatory.                                                                     |                                                            |                                       |             |       |
| Restricted in physically strenuous  activity, but ambulatory and able to  carry out work of a light or  70 | Cares for self, unable to carry on                                                      |                                                                                 |                                                            |                                       |             |       |
| sedentary                                                                                                  | nature                                                                                  | (e.g.,                                                                          | light                                                      | normal activity or to do active work. |             |       |
| housework, office work).                                                                                   | 80                                                                                      | Normal activity with effort; some  signs or symptoms of disease.                |                                                            |                                       |             |       |
| 1                                                                                                          | 60                                                                                      | Requires occasional assistance, but is  able to care for most of his/her needs. |                                                            |                                       |             |       |
| 2                                                                                                          | In                                                                                      | bed                                                                             | <50%                                                       | of                                    | the         | time. |
| Ambulatory and capable of all selfcare, but unable to carry out any                                                                                                            | Requires considerable assistance and                                                    |                                                                                 |                                                            |                                       |             |       |
| work activities. Up and about more  50                                                                     | frequent medical care.                                                                  |                                                                                 |                                                            |                                       |             |       |
| than 50% of waking hours. In bed >50% of the time. Capable  40                                             | Disabled, requires special care and  assistance.                                        |                                                                                 |                                                            |                                       |             |       |
| 3                                                                                                          | of only limited self-care, confined  to bed or chair more than 50% of  waking hours. 30 | Severely                                                                        | disabled,                                                  | hospitalization                       |             |       |
| indicated. Death not imminent.                                                                             |                                                                                         |                                                                                 |                                                            |                                       |             |       |
| 100%                                                                                                       | bedridden.                                                                              | Completely  20                                                                  | Very sick, hospitalization indicated.  Death not imminent. |                                       |             |       |
| 4                                                                                                          | disabled. Cannot carry on any selfcare. Totally confined to bed or  chair. 10                                                                                         | Moribund,                                                                       | fatal                                                      | processes                             |             |       |
| progressing rapidly.                                                                                       |                                                                                         |                                                                                 |                                                            |                                       |             |       |
| 5                                                                                                          | Dead.                                                                                   | 0                                                                               | Dead.                                                      |                                       |             |       |
untitled h1
appendix b information on possible

Information on Possible Interactions with Other Agents for Patients and Their Caregivers and Non-Study Healthcare Team The participant ____________________________ is enrolled on a clinical trial using the experimental agent **MBG453**. This clinical trial is sponsored by Novartis. This form is addressed to the participant, but includes important information for others who care for this participant. MBG453 is an antibody therapy that interacts with the immune system. It is not know to directly interact with other drugs but may have effects including autoimmune or inflammatory responses that may need to be monitored or treated. Because of this, it is very important to tell your study doctors about all of your medicine before you start this study. It is also very important to tell them if you stop taking any regular medicine, or if you start taking a new medicine while you take part in this study. When you talk about your medicine with your study doctor, include medicine you buy without a prescription at the drug store (over-the-counter remedy), or herbal supplements such as St. John's wort. **It is important to inform the study doctor if you are prescribed any** medication that may suppress the immune system, including steroids (such as the drug prednisone). Many health care prescribers can write prescriptions. You must also tell your other prescribers (doctors, physicians' assistants or nurse practitioners) that you are taking part in a clinical trial. Bring this paper with you and keep the attached information card in your wallet Other medicines can be a problem with your study drugs.  
You should check with your doctor or pharmacist whenever you need to use an over-the-counter medicine or herbal supplement.  
Your regular prescriber should check a medical reference or call your study doctor before prescribing any new medicine for you. Your study doctor's name is  
|  Your study doctor's name is _____________________________                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                            |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| INFORMATION ON POSSIBLE DRUG INTERACTIONS                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                            |
| You are enrolled on a clinical trial using the experimental agent  MBG453. Because of this, it is very important to:  Tell your doctors if you stop taking regular medicine or if you start  taking a new medicine.  Tell all of your prescribers (doctor, physicians' assistant, nurse  practitioner, and pharmacist) that you are taking part in a clinical  trial.  Check with your doctor or pharmacist whenever you need to use  an over-the-counter medicine or herbal supplement. | and can be contacted at _________________________________. |