Baseline observations defining

Key Concepts for Creating Analysis Data Sets 84 Defining Variables Once 84 Defining Study Populations 85 Defining Baseline Observations 85 Last Observation Carried Forward (LOCF) 86 Defining Study Day 89 Windowing Data 91 Transposing Data 94... 

If two or more people independently obtain the same frequency recordings when observing the defined behavior or behavioral outcome during the same time period, you have a definition sufficient for an effective DO IT process. Baseline observations of the... 

Use in patients with concomitant illness Sinus bradycardia, defined as heart rate up to 50 bpm and a decrease of at least 15 bpm from baseline, was observed in 1.5% of nefazodone-treated patients compared with 0.4% of placebo-treated patients (P 0.05). Treat patients with a recent history of Ml or unstable heart disease with caution. 

The motivation behind the considerable effort that was exerted in the development of DCV [42, 49, 50, 69] was based on the need to make CV and LSV quantitative tools for the study of electrode kinetics. At that time, there were three major problems that had to be overcome. These were (a) the precision in the measurement of Ep and AEp, (b) the problem with accurately defining the baseline for the reverse sweep and (c) the problem as to how to handle Rn in a practical manner. The development of DCV did indeed provide suitable solutions to all three of these problems, although the methods developed to handle the Ru problem [41, 42] only involve the derivative of the response in terms of precision necessary for the measurements. More recent work [55, 57] is indicative that the precision in Ep/2, Ep) and AEP measurements can be as high as that observed during DCV (see Sect. 3.4). Also, a recent study in which rate constants were evaluated using CV, DCV, and double potential step chronoamperometry for a particular electrode reaction showed that the precision to be expected frcm the three techniques are comparable when the CV baseline, after subtracting out the charging... 

The linear disease progress model (Equation 20.2) assumes a constant rate of change of a biomarker or clinical outcome that reflects the disease status (S) at any time, t, from the initial observation of the patient — for example, at the time of entry into a clinical trial. The rate of change can be defined in terms of a baseline disease status (Sq) and a slope (a), which reflects the change from baseline status with time ... 

Karger (258) estimated the ID50 of 302,668 by giving 14 volunteers Intravenous doses of 5.0 11.0 ug/kg and administering the Number Facility Test at Intervals thereafter. Incapacitation was defined as the making of two consecutive scores below lOZ of the baseline score. A clinical evaluation of incapacitation based on observation of the subjects was also made. Xbc scores on the Number Facility Test yielded an IO50 of 10.1 ug/kg, with 95Z confidence limits of 9.2 and 11.1 ug/kg. The clinical evaluations yielded an estimated IO5Q of 9.5 ug/kg, with 9SZ confidence limits of 8.5 and 10.6 ug/kg. 

Data on the safety of amphotericin deoxycholate have been reported for 50 therapeutic courses in 44 children and adolescents with cancer and a median age of 6.8 years (range 9 months to 18 years) (50). Amphotericin deoxycholate was given in a dose of 1 mg/kg over 2 hours for a mean duration of 7.8 days. Most of the patients received the drug as empirical antifungal therapy in the setting of persistent fever and neutropenia. Nephrotoxicity, defined as a 100% increase in the serum creatinine from baseline, was observed in only one patient. Infusion-related reactions (fevers and/or rigors) occurred in 24% of treatment courses. Thus, amphotericin deoxycholate was relatively well tolerated in this population, although the mean duration of therapy was comparatively short. 

Two studies that compared the interaction of celecoxib with ACE inhibitors found no difference in blood pressure effects compared to placebo [58, 59]. In one study (n=359), the blood pressure (systohc and diastolic) effects of celecoxib 200 mg BID and nabumetone 1 g BID were found to be similar to placebo, but significantly different from ibuprofen 800 mg IID [58]. In the second study (n=178), the effects of celecoxib 400 mg daily and placebo on 24-hour blood pressure in hypertensive patients controlled on hsinopiil 10-40 mg daily was evaluated [59]. No difference between groups was observed in 24-hour ambulatory SBP. The difference between groups in 24-hour diastolic BP was only 1.4 mm Hg. The change from baseline in 24-hour blood pressure (1.8 mm Hg/1.4mm Hg) is less than what has been the effect of NSAIDs on the SBP (defined as an increase >20 mm Hg with an absolute value of >140 mm Hg) reported for traditional NSAIDs in ACE inhibitor-treated patients. On the other hand, co-ad-ministration of rofecoxib 25 mg daily with benazepril 10-40 mg for 4 weeks in patients with mild to moderate... 

The patient population demographics (body weight and baseline Flgb concentrations) were defined based on observed baseline values observed across the three studies. 

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