Page 52 - Abbott

Figure 80. Freedom from Death over the Full Randomized Period (Part 1).

Figure 81. Freedom from HF Hospitalization or Death over the Full Randomized Period (Part 1).

Also performed were an Anderson-Gill Model with Frailty, Anderson Gill Model with Robust Sandwich Estimates (RSE) and Negative
Binomial Regression using an endpoint of time to HF hospitalization or death in Part 1 and Part 1 + Part 2. As seen in the gray rows
in the tables below, all the competing risk analyses taking death into account as a competing risk show that there was no evidence of
a treatment-by-gender interaction if a p-value of 0.05 is used. However, when analyses for interaction by gender are conducted, a p-
value of 0.15 is typically used because the analysis is typically not powered appropriately. When considering a p-value of 0.15, there
was some evidence of treatment-by-gender interaction in the competing risk analyses under the following models:
 AG Model with Frailty for Part 1
 NB Regression for Part 1
 AG Model with Robust Sandwich Estimate for Part 1 + Part 2
 GEE NB Regression for Part 1 + Part 2

Table 9. Results of treatment by gender interaction using different statistical models

Models Estimate SE p-value
Part 1
Cox Model: Endpoint of first HFR hospitalization or Death -0.113 0.289 0.6968
Cox Model: Endpoint of first HFR hospitalization -0.330 0.327 0.3131
AG Model with Frailty: Endpoint of HFR hospitalization or Death -0.373 0.239 0.1211
AG Model with Frailty: Endpoint of HFR hospitalization -0.531 0.262 0.0459
AG Model with RSE: Endpoint of HFR hospitalization or Death -0.433 0.316 0.1712
AG Model with RSE: Endpoint of HFR hospitalization -0.577 0.360 0.1094
NB Regression: Endpoint of HFR hospitalization or Death -0.412 0.242 0.0896
NB Regression: Endpoint of HFR hospitalization -0.573 0.191 0.0027
Part 1 + Part 2
Cox Model: Endpoint of first HFR hospitalization or Death -0.204 0.249 0.4121*

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