What does CSAE stand for?

The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.

The previous safety study presented last year at the American Society of Clinical Oncology-GI showed that BrachySil[TM] in combination with standard chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events related to the device.

In this trial, CTP-347 was well-tolerated at all doses evaluated and there were no clinically significant adverse events reported.

NICE, France -- DATAS results at Cardiostim show reduction of clinically significant adverse events by one-third with DC ICDs Dual chamber implantable cardioverter-defibrillators (DC ICDs) showed greater efficacy in reducing clinically significant adverse events compared to single chamber (SC) ICDs for patients with a standard ICD indication, according to data presented today.

Side effects were comparable to placebo and there were no clinically significant adverse events associated with the formula's amounts of vitamins C and E and zinc.

No clinically significant adverse events were noted.

No clinically significant adverse events were noted.

Food and Drug Administration (FDA) for CT-3, and an initial Phase 1 clinical trial designed to assess the safety of CT-3 showed that it was well tolerated, with no clinically significant adverse events and no evidence of psychotropic activity.