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. 2019 Jun 21;15:100401. doi: 10.1016/j.conctc.2019.100401

Table 6.

Simulated power (%)a results for the less severe placebo group on day 7 of follow-up (p07b  = 0.82).c

Model T1: Constant benefitd T2: Benefit only for first three days T3: Linear decrease in benefit T4: Larger benefit for hospitalized patients T6: Benefit only for last three days T7: Linear increase in benefit
No adjustment for baseline status
Simple Logistic 54.07 63.20 63.42 62.44 36.23 45.35
Sliding Dichotomy 47.75 58.77 56.92 55.50 32.77 39.06
Win Ratio 75.87 76.15 76.16 76.08 76.09 75.59
Proportional Odds 75.90 76.20 76.16 76.13 76.11 75.63
Longitudinal Ordinal Outcome 64.44 44.81 52.52 62.78 65.88 70.26
Cox Proportional Hazards 70.74 99.04 95.81 80.04 15.94 31.88
Accelerated Failure Time (Exponential) 55.18 97.11 90.71 66.84 7.51 17.25
Accelerated Failure Time (Weibull) 75.21 99.11 96.52 83.48 18.67 37.27
Adjustment for baseline status
Simple Logistic 59.39 68.44 69.06 68.29 41.08 50.68
Sliding Dichotomy 49.97 60.64 58.93 57.89 34.40 41.08
Win Ratioe 73.82 72.61 72.31 73.28 77.76 75.46
Proportional Odds 80.52 81.15 80.80 80.68 80.12 79.94
Longitudinal Ordinal Outcome 45.15 6.13 14.09 40.69 71.35 70.70
Cox Proportional Hazards 79.02 99.79 98.50 87.80 17.60 37.29
Accelerated Failure Time (Exponential) 58.68 98.82 94.48 70.81 5.83 16.23
Accelerated Failure Time (Weibull) 82.50 99.79 98.80 90.09 20.03 41.97

Due to the skewness of the less severe placebo group distribution, a treatment effect corresponding to T5 that approximated an odds ratio of 1.77 on day 7 could not be found.

a

Power (%): percentage of the 10,000 simulated datasets in which the Wald test statistic for the estimated treatment effect of the fitted model was significant at the two-sided 0.05 level. Power for the top three models for each treatment effect with or without adjustment for baseline health status is printed in bold.

b

p07 denotes the probability of discharge (i.e., categories 5 and 6 of the ordinal endpoint combined) by day 7 of follow-up for the placebo group.

c

Supplementary Table 3 displays the category percentages for the less severe placebo group on day 7 and each of the six IVIG groups.

d

Benefit refers to the differences in transition probabilities between randomized groups across treatment effects.

e

Unlike all other models which include a covariate to adjust for baseline status, the win ratio stratifies by only comparing patients who started at the same baseline category between randomized groups.