Case reporting systems

Once it is determined that data exist, the next step is to begin the collection process. If sufficient thought and training is provided in the development and operation of the maintenance and operating reporting systems, much of the collection process can be automated. Automation assumes that a well-thought-out taxonomy is in place. If this is not the case, then an analyst must collect and review the records manually. In either case, the analyst must collect data from the plant sources previously discussed in order to determine the numerator (number of failures within a unique plant equipment population), and denominator (the operating time or number of demands for the equipment) of the equation to calculate failure rates. 

Case reports of human poisonings and studies in animals indicate that during acute oral exposure to lethal or near-lethal amounts of endosulfan, involvement of a large number of organ systems (respiratory,... 

Thompson GS, Quan K, DuChene A. Case report form image management system for large multicenter clinical trials. Controlled Clin Trials 2001 P34. 

Of note, allied health care professionals soon may routinely assume a role as referring TeleStroke providers at spoke hospitals a recent case report documented the first delivery of rt-PA by an advance practice nurse in the ED at a hospital in rural Texas networked by a TeleStroke system to a stroke center in Houston. ... 

Gastrointestinal Effects. Case reports indicate that acute inhalation exposure to trichloroethylene results in nausea and vomiting (Buxton and Hayward 1967 Clearfield 1970 David et al. 1989 DeFalque 1961 Gutch et al. 1965 Milby 1968). Anorexia, nausea, vomiting, and intolerance to fatty foods have also been reported after chronic occupational exposure to trichloroethylene (El Ghawabi et al. 1973 Schattner and Malnick 1990 Smith 1966). Trichloroethylene-induced efiects on the autonomic nervous system may contribute to these effects (Grandjean et al. 1955). Some of the people exposed to trichloroethylene and other chlorinated... 

Azathioprine, mycophenolate mofetil, and enteric-coated MPA are not metabolized through the CYP isozyme system therefore, they do not experience the same DDI profiles as cyclosporine, tacrolimus, and sirolimus. Azathioprine s major DDIs involve allopurinol, angiotensin-converting enzyme (ACE) inhibitors, aminosalicylates (e.g., mesalamine and sulfasalazine), and warfarin.11 The interaction with allopurinol is seen frequently and has clinical significance. Allopurinol inhibits xanthine oxidase, the enzyme responsible for metabolizing azathioprine. Combination of azathioprine and allopurinol has resulted in severe toxicities, particularly myelosuppression. It is recommended that concomitant therapy with azathioprine and allopurinol be avoided, but if combination therapy is necessary, the azathioprine doses must be reduced to one-third or one-fourth of the current dose. Use of azathioprine with the ACE inhibitors or aminosalicylates also can result in enhanced myelosuppression.11 Some case reports exist demonstrating that warfarin s therapeutic effects may be decreased by azathioprine.43-45... 

The final meddra data set in this program contains the lower-level term code (llt code) that can then be merged with the adverse events or medical conditions database. By merging the MedDRA dictionary data with the disease data, you can match the verbatim event text captured on the case report form with the preferred term and associated body system. Then you can summarize these data by body system and preferred term you will see an example of this in Chapter 5. 

Mineral Oil Hydraulic Fluids. There is limited information on the toxicity of mineral oil hydraulic fluids in humans. A single case report of a child accidentally ingesting a single dose of automotive transmission fluid provides limited information on death and systemic effects. A case-control study provides some information on the carcinogenicity of mineral oil hydraulic fluids. The study population was exposed via inhalation and dermal routes. An occupational exposure study provides information on neurotoxicity following chronic dermal exposure. Information on the toxicity of mineral oil hydraulic fluids is limited to a series of inhalation, oral, and dermal acute-duration exposures. These studies provide information on death, systemic effects, and neurotoxicity by inhalation, oral, and dermal routes, and immunotoxicity following dermal exposure. 

Hereditary deficiency of phosphoglycerate kinase (PGK) is associated with hereditary hemolytic anemia and often with central nervous system dysfunction and/or myopathy. The first case, reported by Kraus et al. (K24), is a heterozygous female, and the results are not so clear. The second family, reported by Valentine et al. (V3), is a large Chinese family, whose pedigree study indicates that PGK deficiency is compatible with X-linked inheritance. To date, 22 families have been reported (04, T25, Y3). Nine of these have manifested both symptoms five have shown only hemolysis seven have shown the central nervous system dysfunction and/or myopathy but without hemolysis and one case, PGK Munchen, is without clinical symptoms (F5). PGK II is an electrophoretic variant found in New Guinea populations (Y2). Red blood cell enzyme activity, specific activity, and the kinetic properties of this polymorphic variant are normal. 

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