Safety interim analysis

Findlay A, Serrano C, Punzalan S, Fan SL. Increased peritoneal dialysis exit site infections using topical antiseptic polyhexamethylene bigu-anide compared to mupirocin results of a safety interim analysis of an open-label prospective randomized study. Antimicrob Agents Che-mother 2013 57(5) 2026-8. 

De Angelo, D.J. et al.. Interim analysis of a phase If study of the safety and efficacy of gemtuzumab ozogamycin (Mylotarg) given in combination with cytarabine and daunorubicin in patients <60 years old with untreated acute myeloid leukemia, Proc. Am. Soc. Hem., 100,198a, Abstr. 745, 2002. 

The trial was, in fact, stopped at the interim analysis due to futility the conditional power, was well below 30 per cent. In addition, even though the formal boundary for safety was not crossed, the trend was in the direction of excess deaths in the ancrod group. 

Periodic review of interim analysis of safety data by DSMB... 

S.L. Rogers, L.T. Friedhoff, Long-term efficacy and safety of donepezil in the treatment of Alzheimer s disease an interim analysis of the results of a US multicentre open label extension study, Eur. Neuropsychopharmacol. 8 (1998) 67-75. 

The code will be broken and data will be analyzed when the 12-mo follow-up has been completed for all patients. At that time, DHA therapy will be offered to all patients who desire to receive it. Clinical and laboratory studies will be monitored by an independent data and safety monitoring committee. This committee will also perform an interim analysis when 30 patients have completed assessment and has permission to terminate the study if there are significant favorable findings or unanticipated adverse outcomes. A determination of statistical power indicates that this sample size is sufficient to detect a major effect (0.862 standard deviations). With a more modest effect of 25%, however, the statistical power diminishes to 60%. The study has been approved by the Institutional Review Board at the Johns Hopkins Medical Institutions and is supported by a research grant from the Office of Orphan Products Development at the Food and Drug Administration. Fifty-two patients are enrolled in the study at this time. The code has not yet been broken. No adverse effects attributable to the medication have been observed. 

All four trials currently ongoing have successfully passed preplanned interim safety analyses. Intergroup and NSABP trials were granted FDA approval for a joint interim efficacy analysis including 3351 patients. The HERA trial performed a pre-planned interim efficacy analysis at 475 events including 3387 evaluable patients. These analyses, presented during AS CO 2005, showed a reduction in the risk of recurrent disease of 52% (joint interim analysis) and 46% (HERA interim... 

Data from the interim analysis showed no study-drug-related serious or non-serious adverse events on the FTP Continuation study. In a foUow-up safety assessment across aU rAHF-PFM studies, one non-ser-ious adverse event was reported in one patient on the PTP Continuation study. This event (strange taste in the mouth) was deemed possibly related to rAHF-PFM, and was completely resolved. 

No inhibitors to FVIII have been detected in patients included in the interim analysis. A follow-up safety assessment across all rAHF-PFM studies provided additional data on inhibitor risk for 50 patients who had accumulated at least 50 exposure days to rAHF-PFM. No inhibitors were detected in this expanded cohort from the PTP Continuation study. 

Moreover, in a subseqnent interim analysis of fractnres in a large, ongoing, controlled clinical trial, preliminary analysis are reported as being consistent with the resnlts from the ADOPT-study (http //www.fda.gOv/MEDWATCH/SAFETY/2007/ Avandia GSK Ltr.pdf). 

A third reason for termination concerns the safety-risk dimension. If there is compelling evidence at the time of an interim analysis that the drug is unacceptably toxic, termination is appropriate. From the perspective of this book s discussions, the same logic would apply in cases where there was compelling evidence that the drug was acceptably safe, i.e., it is not associated with unacceptable cardiovascular risk. 

Hiatt WR, Kaul S, Smith RJ (2013) The cardiovascular safety of diabetes drags-4nsights from the rosiglitazone experience. N Engl J Med 369 1285—1287 Home PD, Pocock SJ, Beck-Nielsen H, RECORD Study Group et al (2007) RosigUtazone evaluated for cardiovascular outcomes-an interim analysis. N EngJ J Med 357 28—38 International Diabetes Federation (2013) IDF Diabetes Atlas, 6th edn. Available at. http //www.idf. 

Three months after the training 346 safety attitude questionnaires were administered. At the time of writing there have been 41 returns (response rate of 12 per cent). Insufficient data are eurrently available to allow statistically valid conclusions to be drawn. Interim analysis suggests no significant change in the climates of safety or teamwork. Preliminary data are displayed in Table 19.2. 

Ref. (61)]. The interim results confirmed the feasibility and safety of using E2F-I decoy. Analysis of the secondary endpoints using quantitative coronary angiography and three-dimensional intravascular ultrasound demonstrated increased patency and adaptive vessel remodeling characterized by reduction in neointimal size and volume in the treated group one year after treatment, leading to 40% reduction in critical stenosis. These results will now need to be confirmed in adequately sampled and powered phase III studies in patients with coronary and peripheral vessel disease in order to further... 

On April 4, 2003, the committee provided the DOE with its interim report, which includes four management-related recommendations focused on the areas of systems analysis, exploratory research, safety, and organization (see Appendix B). The committee is pleased to acknowledge that the director of the DOE Office of Hydrogen, Fuel Cells, and Infrastructure Technologies and others in the DOE immediately began action to respond to those recommendations. In this chapter, the committee presents some additional perspectives related to systems analysis and management. 

D Amico DJ, Goldberg MF, Hudson H, et al. Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD) interim (month 6) analysis of clinical safety and efficacy. Anecortave Acetate Clinical Smdy Group. Retina 2003 23 14. 

The following parameters will be listed and analyzed both for the final analysis and for the interim safety evaluations by the independent data monitoring committee ... 

DOE 0 420.1 Facility Safety Requires fire hazard analysis and natural phenomena analysis for all facilities. For Hazard Category 2 or 3 nuclear facilities only, requires a criticality safety evaluation. Criticality Safety Analysis Fire Hazard Analysis Effects of natural phenomena hazards on facility systems, structures, or components (SSCs) included as part of safety analysis documented in the Safety Analysis Report (SAR), Basis for Interim Operation (BIO), or Auditable Safety Analysis (ASA). 

As an interim measure operational constraints were imposed as the frequency of failures could have invalidated the risk analysis in the safety report, and hence jeopardised the authorisation to operate the plant. Meanwhile the AHXs were heavily instrumented with strain gauges and thermocouples to identify the cause of the problem and indicate a solution. 

DOE Order 5480.23, Nuclear Safety Analysis Reports (DOE 1992b), This order specifies the requirements for nuclear facilities to document the safety analyses that establish the adequacy of the facility safety bases. A Safety Analysis Report (SAR) is required to document the results of the safety analysis for the facility. Furthermore, as part of the SAR, the contractor is responsible for addressing the Derivation of TSRs as indicated in Section 8 under Requirements, Part b, "Scope and Content of the SAR", subsection (p). The Attachment to the Order, "Interim Guidance for DOE Order 5480.23 - SARs," Section 4, "Interpretation," Part f. Subsection d.16, provides additional guidance on the content. 

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