Hemorrhagic Events. Bleeding was the most frequent adverse event observed in patients treated with REFLUDAN. The following table gives an overview of all hemorrhagic events which occurred in at least two patients.

Patients with TECs       Hemorrhagic   Events*       HAT-1   HAT-2   (All Patients)   (n=198)       REFLUDAN   (n=113)       Historical   Control (n=91)         Bleeding from     puncture sites and     wounds       14.1%       10.6%       4.4%         Anemia or isolated     drop in hemoglobin       13.1%       12.4%       1.1%         Other hematoma     and unclassified     bleeding       11.1%       10.6%       4.4%         Hematuria       6.6%       4.4%       0         Gastrointestinal     and rectal bleeding       5.1%       5.3%       6.6%         Epistaxis       3.0%       4.4%       1.1%         Hemothorax       3.0%       0       1.1%         Vaginal bleeding       1.5%       1.8%       0         Intracranial bleeding       0       0       2.2%
* Patients may have suffered more than one event.

Patients with TECs       Nonhemorrhagic   Events*       HAT-1   HAT-2   (All Patients)   (n=198)       REFLUDAN   (n=113)       Historical   Control (n=91)         Fever       6.1%       4.4%       8.8%         Abnormal liver     function       6.1%       5.3%       0         Pneumonia       4.0%       4.4%       5.5%         Allergic skin     reactions       3.0%       3.5%       1.1%         Heart failure       3.0%       1.8%       2.2%         Abnormal kidney     function       2.5%       1.8%       4.4%         Unspecified     infections       2.5%       1.8%       1.1%         Multiorgan failure       2.0%       3.5%       0         Pericardial effusion       1.0%       0       1.1%         Ventricular fibrillation       1.0%       0       0
* Patients may have suffered more than one event.

Other hemorrhagic events (hemoperitoneum, hemoptysis, liver bleeding, lung bleeding, mouth bleeding, retroperitoneal bleeding) each occurred in one individual among all 198 patients treated with REFLUDAN.

Please consult full Prescribing Information for a complete list, including the incidence, of adverse events.

A Proven Safety Profile Adverse Events Reported in Clinical Trials in HIT Patients