General Instructions for CRF 3 Rev H To be completed at each follow up visit Patient Identification and Group Date of Visit Assessment performed physician by. IMPORTANT OUTCOME MEASURE Provide start and stop date of adjuvant therapy. This should be completed at each visit until patient no longer receiving adjuvant therapy. Disease free? Recurrence? IMPORTANT OUTCOME MEASURE Verify CRF is Rev H Date of Mammogram Radiation Recall Reaction: May occur following chemotherapy in the absence of additional radiation therapy. Survival Status If mammogram not performed DO NOT complete this section. If change from previous visit, specify why Attempt to contact patient at least 3x prior to entering as Lost to F/U.

General Instructions for CRF 4 – Adverse Events To be completed at each follow up visit Patient Identification and Group Date of Visit Describe all adverse events using medical terminology, ie, desquamation, pain in breast, drainage, etc. using definitions provided for in coding. Other Events Adverse Event Example: New event of breast pain occurs on 6/4/04. A start date will be entered but if it is not resolved, it will be checked as Under Observation. Adverse Event Example: Erythema starts on 5/6/04 and is still present at next visit. You will list it again and check ongoing. You do not need to repeat the start date as the event is ongoing. Adverse Event? YES or NO See Definitions CRF 4, pg 2 Is event ongoing from last visit? Not a new event? Is this a Serious AE? Death or threat to life, permanent impairment, requires medical or surgical Intervention to preclude permanent impairment Is the event under observation? Not resolved? Provide start and stop date Intervention: Be specific

Adverse Event Definitions To be used as a guide to completing CRF 4, Page 1