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Reliable information on patients' medical history and on the use of concurrent medication was obtained from 105 patients (71% male; mean age 38 years [SD = 8]) by personal interview and by review of the clinical records.
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The use of concurrent medications or interventions is often restricted, so any witnessed effect can be attributed to the intervention of interest.
Previous RCTs in this field were conducted with the limitation of highly selected patient populations and the restricted use of concurrent medications, and such designs do not correspond with an actual clinical setting.
Pyoderma and otitis externa are often associated with atopic dermatitis and the observed incidence in this study may have been a result of the prohibition of the use of concurrent medications, notably antibiotics and otic preparations, usually used to manage these signs.
Risk factors for development of contrast-induced nephropathy include pre-existing renal dysfunction (especially diabetic nephropathy and multiple myeloma-associated nephropathy), dehydration, congestive heart failure and use of concurrent nephrotoxic medication (including aminoglycosides and amphotericin B).
It was not possible to determine if the initial use of concurrent immunosuppressive medication could the development of an immune response to romiplostim due to low numbers of subject population who developed antibodies.
27 A list of concurrent medications was maintained.
With increasing numbers of concurrent medications, the risk of adverse drug events increases significantly.
In all subgroups, the use of multiple concurrent medications increased.
Other exclusion criteria were: use of concurrent lipid altering medication or antioxidant vitamins, renal or hepatic dysfunction, and use of medication known to affect metabolism of atorvastatin or simvastatin.
Since the use of concurrent immunosuppressive rescue medication was markedly reduced in romiplostim-dosed subjects, immunogenicity assessment to romiplostim was not compromised.
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