7068 Background: Bevacizumab (BV) added to chemotherapy prolongs survival in non-squamous NSCLC, but was uncommonly associated with serious pulmonary hemorrhage (PH) (Sandler A, et al, ASCO 2005). A retrospective study was conducted to potentially identify clinical or radiographic (CT) risk factors associated with early onset (<150 days from initial treatment) PH. Methods: A broad search of the E4599 database for selected bleeding terms among BV-treated patients was conducted. Cases of PH were identified and adjudicated. Associations between baseline clinical factors and incidence of PH were evaluated in the full cohort of E4599 patients. In addition, a separate case-control analysis, using controls matched on age and sex, was conducted to evaluate baseline CT variables. Chest CTs were evaluated by blinded independent assessment of lesion location, cavitation, size of largest tumor or nodal mass, vascular involvement, presence of an endobronchial tumor, and total number of intra-thoracic lesions. Additional analyses were also conducted including cases of late-onset PH, post-baseline variables such as unconfirmed tumor response at 6 weeks (RECIST) and cavitation, and combined CT data from E4599 and an earlier Ph II trial. Results: Of 425 BV-treated pts, 10 cases of PH were identified. Of these, 7 were PH without additional complicating factors, and 6 were of early-onset. The cohort analysis of these 6 early-onset cases is presented ( table ). The case-control analysis on CT risk factors is ongoing. Conclusion: PH was an uncommon event, and based on this, no evidence was observed for an association between the baseline clinical variables and the incidence of early-onset events of PH without additional complicating factors. Conclusions for the CT variables evaluated will be presented. [Table: see text] [Table: see text]