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Appendix H: Statistical Analysis of Mortality in the FIAU/FIAC Clinical Trials
Pages 256-265

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From page 256...
... . None of the trials involved a randomized control group, hence, statistical assessments of the results observed must be based on the assumed background mortality rates applying to the populations under study.
From page 257...
... The true underlying rates may, in reality, be higher than the levels indicated for the set carrying that label. For example, the median life expectancy for the population enrolled into R89 (AIDS patients with CMV)
From page 258...
... Power is the probability of rejecting the null hypothesis, that the test treatment has no effect on mortality, when, in fact, it has the indicated negative or positive effect. Powers of 0.80 or higher are desired when designing randomized controlled trials with a calculated sample size.
From page 259...
... The expected number of deaths is the sum of the products of person years of experience from a specific trial multiplied by the presumed underlying mortality rate for that study population; for example, 0.10~6.0)
From page 260...
... Neither of the analyses in Tables H-6 or -7 take account of actual amount of drug administered and, hence, are not helpful in addressing the broader question as to whether the studies taken together are indicative of increasing probability of death with increased exposure to the drug. The relative risk (per unit increase of dose on the log scale)
From page 261...
... R90-001: The tolerance of HIV-infected patients with herpes-group infections to oral doses of FIAU. R91-010: FIAU oral dose-ranging study in patients with compensated chronic hepatitis B
From page 262...
... 262 Table H-2. Death Experience by Calendar Time REVIEW OF THE FIALURIDINE CLINICAL TRL4LS Cum.
From page 263...
... Results per Individual Trial for Intermediate Underlying Mortality Rates Rate N Avis Person-yrs Deaths Exp Obs Diff p-value Power . Neg Pos 26 week followup R 89 0.15 12 0.50 5.10 5.19 0.90 3 2.10 0.12 0.10 0.07 R 90 0.08 43 0.50 19.78 21.50 1.72 0 -1.72 0.22 0.13 R 91 0.03 24 0.50 11.64 11.92 0.36 1 0.64 0.60 0.07 0.06 Total 79 0.50 36.52 38.61 2.98 4 1.02 0.70 27 June 93 followup R 89 0.15 12 3.58 36.52 30.49 6.44 4 -2.44 0.23 0.24 0.16 R 90 0.08 43 1.50 59.34 62.97 5.16 4 -1.16 0.49 0.32 0.20 R 91 0.03 24 1.33 30.96 31.01 0.96 1 0.04 1.00 0.09 0.07 PPPC 0.03 15 0.13 1.89 1.95 0.06 0 -0.06 0.24 0.05 0.05 Total 94 1.50 128.71 126.42 12.62 9 -3.62 0.24 Assumptions and notes: Enrollment period from 1st dose to last dose; uniform rate of enrollment over that period; instantaneous treatment effect (i.e., no treatment lag)
From page 264...
... ; instantaneous reports of deaths; 100% followup for mortality over defined followup period; assumed underlying annual mortality rates: R89, 0.20; R90, 0.12; and R91, 0.04. Table H-6.
From page 265...
... R90 12 6.6 3 1.0 2.000 0.16 R91 51 49.0 4 5.3 -1.300 0.45 PPPC 79 1 13.1 9 10.0 -1.000 0.66 High (R89 0.20; R90 0.12; R91 0.04) R90 12 6.6 3 1.3 1.700 0.28 R9 1 51 49.0 4 7.4 -3.400 0.13 PPPC 79 1 13.1 9 14.2 -5.200 0.11 Assumptions and notes: Enrollment period from 1st dose to last dose; uniform rate of enrollment over that period; instantaneous treatment effect (de, no treatment lag)


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