Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of < 3.0. A lower time in therapeutic range was associated with a higher risk of CRB. Conclusions CRB is a frequent complication in cancer patients with VTE during anticoagulant treatment, and is associated with age > 75 years and intracranial malignancy.

A 65-year-old retired government officer presented to Department of Medicine of All India Institute of Medical sciences, New Delhi, India, with the complaints of high grade fever and significant weight loss for the last five months. He was a known case of Type 2 diabetes mellitus with good glycemic control on oral hypoglycemic agents (Tab Glimipiride 2 mg, Metformin 500 mg and Voglibose 0.3 mg daily). Patient denied any exposure to bird droppings or excessive dust from nearby civil construction or high risk behaviour. Besides, there was no past history of tuberculosis or contact with a patient with pulmonary tuberculosis.At the time of presentation, patient had fever and tachycardia. His body weight was 51 kg. Other general physical examination was unremarkable. Abdominal examination revealed mild hepatosplenomegaly with no free fluid. Other systems examination was non contributory. Hematological and biochemical investigation revealed an elevated ESR of 103 mm in first hour, deranged hepatic and renal function tests (serum creatinine 1.2 mg/dl, urea 53 mg/ dl, uric acid 8.9 mg/dl, AST 89 IU/L, ALT 49 IU/L, and Alkaline phosphatase 1022 IU/L). His fasting blood sugar was 153 mg/dl and HbA1c was 6.5%.Urine and blood cultures were sterile and peripheral smear for malaria was also negative. Chest radiograph was normal. Ultrasound abdomen revealed mild hepatosplenomegaly with bilateral adrenal masses. CECT of chest and abdomen showed fine miliary mottling

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