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However, this study specific approach might miss important patient relevant events. An alternative approach utilizes the Medical Dictionary for Regulatory Activities MedDRA Standardized MedDRA Query SMQ tool; SMQs are validated database interrogation tools . The Toxic/Septic Shock SMQ contains multiple, clinically important pneumonia complications eg, sepsis, respiratory failure. A study database could be interrogated readily using this SMQ to define the plus for an ACM+ endpoint. The frequencies of plus events were examined for Shionogi studies using nonfatal toxic/septic shock SMQ AEs including SAEs and SAEs Table 3 is an example, using Dori 08 and 10. With variability by study and treatment group, ACM+ demonstrates an increased endpoint event frequency over ACM alone Table 4. ACM+ rates using toxic/septic shock SMQ SAEs were compared to ACM rates alone for Dori 08 and Dori 10; addition of the plus events increased the doripenem event rates in Dori 08 this study had a significantly higher ACM for doripenem treatment; in contrast, in Dori 10, for which ACM was comparable for doripenem and comparator, the ACM+ analysis did not present any signal compare Figure 1A to Figure 1B and Figure 1C to Figure 1D. Summary of Serious Adverse EventsToxic Septic Shock Standardized Medical Dictionary for Drug Regulatory Activities Query All Treated Population, Dori 08, 09, 10Abbreviations: HABP, hospital acquired bacterial pneumonia; MedDRA, Medical Dictionary for Drug Regulatory Activities; SAE, serious adverse event; SMQ, standardized medical query; VABP, ventilator associated bacterial pneumonia. Summary of Serious Adverse EventsToxic Septic Shock Standardized Medical Dictionary for Drug Regulatory Activities Query All Treated Population, Dori 08, 09, 10Abbreviations: HABP, hospital acquired bacterial pneumonia; MedDRA, Medical Dictionary for Drug Regulatory Activities; SAE, serious adverse event; SMQ, standardized medical query; VABP, ventilator associated bacterial pneumonia. Abbreviations: ACM, all cause mortality; ACM+, mortality plus all cause mortality plus toxic/septic shock standardized Medical Dictionary for Regulatory Activities query adverse events; HABP, hospital acquired bacterial pneumonia; VABP, ventilator associated bacterial pneumonia. Abbreviations: ACM, all cause mortality; ACM+, mortality plus all cause mortality plus toxic/septic shock standardized Medical Dictionary for Regulatory Activities query adverse events; HABP, hospital acquired bacterial pneumonia; VABP, ventilator associated bacterial pneumonia.
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, 2003. Illustrated edition. 288 pages. ISBN: 073870301X. Learning Ritual Magic: Fundamental Theory and Practice for the Solitary Apprentice. By John Michael Greer, Earl King, Jr. , and Clare Vaughn. Boston, Massachusetts, Weiser Books, 2004. Index, bibliography, 271 pages. ISBN: 1578633184. VSCL.
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In order to deal with this problem, the use of a Tactile Image Enhancer TM from Repro Troniks TM was used. Various standard computer graphing packages such as MathCad, Maple, and Mathematica were modified to produce graphs with Braille labels created by the Duxbury Braille Font for Windows TM. After printing these images in ink, the images were transferred via Xerox to Tactile Image Enhancement paper and converted into a raised Tactile Image via the Tactile Image Enhancer. When appropriate, these graphs and diagrams were embedded in the Braille text of the document by cutting and pasting. For images that are not reproducible by the computer or available in electronic format, scanners were used with a graphics program like CorelDraw TM to produce ink output for subsequent image enhancement. This general technique, like the equation translation, has two advantages: the ability to accept electronic forms of diagrams for enhancement, and the overall speed of the process.
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