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Safety Analyses Safety analyses will be based on all subjects who were randomized to a test or to the placebo procedure group, completed the baseline assessment, and received at least the first study procedure with the Resonator™ device. Safety will be assessed by evaluating and comparing frequency and incidence of observed and/or reported adverse events between test and placebo procedure groups. A chi-square test with a continuity correction will be performed to compare the percentage of subjects who had adverse events and/or reactions between the test and placebo group subjects. Anticipated potential adverse events resulting from use of the Resonator™ device are:
Subjects will record any potential adverse events in the daily subject diary, and report these recordings to the PI right away. In addition, formal evaluation of the occurrence of any adverse events will take place at each of a subject‟s test site visits. The investigator will record the observation or report of any adverse event and assign the relationship to the study intervention on the appropriate case report form in the subject‟s file and will report the occurrence to the governing IRB, if and as appropriate, within 5 days of the reported occurrence, or within 24 hours in the occurrence of a serious adverse event including death. Adverse events will include any baseline symptoms which increase in duration, frequency, or intensity greater than that which could reasonably be expected given the variable nature of fibromyalgia. Early Termination Visit If a subject withdraws or is terminated from the study prior to completion of the 2-week procedure administration period and the subsequent day 14 evaluation visit, he or she will be scheduled for an early termination visit at the clinical site during which time the evaluations listed under the IMMEDIATE POST-PROCEDURE ASSESSMENT: STUDY ENDPOINT START: DAY 14 visit will be applied. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
