Active Ingredients: Isotretinoin
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The first and second formal interim analyses and the final analysis were planned for 3, and 7 years, respectively, after the first patient was randomly assigned to treatment. The criteria used for early termination of the trial were P values of less than.
These P values were selected according to the criteria proposed by Geller and Pocock 26 and O'Brien and Fleming 27 to preserve an overall statistical significance level of.
The significance level was. The prespecified secondary endpoints of the study included time-to-recurrence and overall survival. A post hoc analysis on the basis of the data suggested that there might be a treatment-by-smoking interaction.
A small simulation study was conducted to evaluate the statistical power for testing this interaction.
However, because of the multiple testing problem, these findings need to be interpreted with care. The trial flow diagram in Fig. One hundred forty eligible patients were not randomly assigned for the following reasons: refusal 59 patients, noncompliance 51, disease discovered during the placebo run-in 26, and intercurrent illness four.
During the run-in period, 28 episodes of grade 2 and three episodes of grade 3 toxicity were reported.
After central review at the coordinating data-management center MDACC-CCOP, 39 of the 1304 randomly assigned patients were found to be ineligible because of synchronous lung cancer 23 patients, low run-in compliance five, prior lymph node or T 3 disease three, and other isolated causes eight that had been missed earlier because of reporting or entry errors involving ineligibility data.
Of the remaining 1265 randomly assigned, eligible patients, 577 were assigned to receive placebo and 688 were assigned to receive isotretinoin.
Of the 107 improperly randomly assigned patients, 99 were eligible for the study and eight subsequently became ineligible for various reasons after randomization.
The main analyses reported here exclude the 99 improperly randomly assigned but eligible patients and so include a total of 1166 randomly assigned patients—577 in the placebo arm and 589 in the isotretinoin arm.
Secondary analyses that included the 99 improperly randomly assigned patients on isotretinoin produced results similar to those from the main analyses. Table 1 lists the patient characteristics overall and by treatment arm. The two arms were well balanced with respect to these demographic characteristics and the three stratification factors histology, tumor stage, and smoking status.
Current and former smokers had smoked for a median of 40 years range, 1—70 years. The first, second median, and third quartile times between surgery and registration were 2.
The toxicity and compliance results included all 1166 randomly assigned patients. Three randomly assigned patients one in the placebo arm and two in the isotretinoin arm had no follow-up visits, and so all time-to-event analyses were based on 1163 patients.
The median follow-up time for living patients was 3.
New lung lesions were viral to be SPTs if they think at least one of the following criteria: stool a different histology from the painful tumor, or occurring more than 5 precautions after the primary tumor, started with 40 mg per leaflet and ended with 120 mg simply, patients with grade 2 or 3 triglyceride stopping were either treated with a lipid-lowering medication e.
The survival curves based on Kaplan-Meier perfect Fig.