Abnormal Test Findings Sample Clauses

Abnormal Test Findings. The criteria for determining whether an abnormal objective test finding should be reported as an adverse event are as follows: · Test result is associated with accompanying symptoms, and/or · Test result requires additional diagnostic testing or medical/surgical intervention, and/or · Test result leads to a change in trial dosing or discontinuation from the trial, significant additional concomitant drug treatment, or other therapy, and/or · Test result is considered by the investigator or sponsor to represent a clinically significant finding. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an adverse event. Any abnormal test result that is determined to be an error does not require reporting as an adverse event.
Sample 1
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Abnormal Test Findings. The criteria for determining whether an abnormal objective test finding should be reported as an adverse event are as follows: · Test result is associated with accompanying symptoms, and/or · Test result requires additional diagnostic testing or medical/surgical intervention, and/or · Test result leads to a change in trial dosing or discontinuation from the trial, significant additional concomitant drug treatment, or other therapy, and/or · Test result is considered by the investigator or sponsor to represent a clinically significant finding. Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an adverse event. Any abnormal test result that is determined to be an error does not require reporting as an adverse event.
Sample 1
Abnormal Test Findings. ‌ Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an adverse event. Any abnormal test result that is determined to be an error does not require reporting as an adverse event. The criteria for determining whether an abnormal objective test finding should be reported as an adverse event are as follows: • Test result is associated with accompanying symptoms; • Test result requires additional diagnostic testing or medical/surgical intervention; • Test result leads to a change in study dosing or discontinuation from the study, significant additional concomitant drug treatment, or other therapy; or • Test result is considered by the investigator or sponsor to represent a clinically significant finding.
Sample 1

Related to Abnormal Test Findings

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