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Varsha ★ 2014-09-01 16:36 (3882 d 17:08 ago) Posting: # 13447 Views: 5,760 |
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Dear all, We have conducted one BA BE study where at the time of screening, the volunteers were having normal ESR values but the post study safety reports after the drug administration reveals increase clinically significant ESR values and were considered as adverse event for nearly 18 subjects out of 48 subjects. The physician has documented the AE as not related to the drug as there is not linerature evidence for the same. My concern is, is the documentation correct? What may be the reason for increase of ESR values for all these subjects. Regards, Varsha |
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ElMaestro ★★★ Denmark, 2014-09-01 18:59 (3882 d 14:45 ago) @ Varsha Posting: # 13448 Views: 4,545 |
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Hello Varsha, ❝ We have conducted one BA BE study where at the time of screening, the volunteers were having normal ESR values but the post study safety reports after the drug administration reveals increase clinically significant ESR values and were considered as adverse event for nearly 18 subjects out of 48 subjects. The physician has documented the AE as not related to the drug as there is not linerature evidence for the same. Very unusual, it falls outside any ordinary routine, I would say. No idea what the answer really is in the absense of more info about the drug identity. Let's hear what drug this is. Makes it easier to guesswork a little. In addition: Was ESR measured in-house or out? Did you review the ESR measurements where it took place? Anything else out of the ordinary in the trial? Did you see it in true quanta in both T and R? (If the occurence was mainly in either T or R: measure potency of the drugs from the retention samples, consider a call to your local regulator) ❝ My concern is, is the documentation correct? What may be the reason for increase of ESR values for all these subjects. Well, sooner or later one could say the staff should become suspicious (meaning kind of: not related could become possibly related if or when a new side effect is discovered). No idea how to define what that point in time comes. Am eager to hear other opinions... — Pass or fail! ElMaestro |
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Varsha ★ 2014-09-02 08:47 (3882 d 00:57 ago) @ ElMaestro Posting: # 13450 Views: 4,517 |
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❝ Hello ELMaestro, Thanks for your response. Few clarification which you require: ❝ Let's hear what drug this is. Makes it easier to guesswork a little. The drug is tolterodine Tartrate, ❝ Was ESR measured in-house or out? ESR measured from an outsourced diagonistic lab. ❝ Did you review the ESR measurements where it took place? till now we didin'e talk with the lab. ❝ Anything else out of the ordinary in the trial? rest is satisfactory in the trial. ❝ Did you see it in true quanta in both T and R? the events occured in both test and reference. Kind regards Varsha |
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ElMaestro ★★★ Denmark, 2014-09-02 09:40 (3882 d 00:04 ago) @ Varsha Posting: # 13451 Views: 4,550 |
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Hello Varsha, I think your finding is quite out of the ordinary and interesting, and not necessarily alarming. I assume and hope all AEs have resolved. I would definitely look into this. Visit the lab, be physically present, open books, check data, instruments/calibrations and whodunnit. Look into your own records to check if you have subjects in other trials analysed for ESR in the same timeframe, and review their ESR's as well. And ask if other trials recently have been associated with weird ESR issues (which they might not be willing to share with you). — Pass or fail! ElMaestro |
Ing. Helmut Schütz