Baseline demographic and background variables will be summarized for the patients enrolled in the Registry using descriptive statistics. For categorical variables, frequencies and percentages will be presented. Refer to the Data Reports section of the Gaucher Registry Manual for a more detailed explanation of available data requests and the process for requesting a report. Although written informed consent is not required by the Registry, it is strongly recommended. If supplemental laboratory or radiology reports are submitted to the Registry, the patient s name should be deleted and the patient s initials and ID number should be added to each attached page.
All physician information is confidential.
Furthermore, physician-specific patient data will remain confidential and will not be released to other physicians without prior written approval. No physician to physician data comparisons will be made. The patient may decline to participate or withdraw consent at any time. It is the responsibility of Genzyme Corporation to collect, review, and communicate all relevant information regarding adverse events for patients receiving Cerezyme and Ceredase to the U.S Food and Drug Administration and the regulatory authorities in other countries where these drugs are approved for marketing. The Gaucher Registry is sponsored by Genzyme Corporation.