TABLE 1.
Examples of variables and variate exposure–response analyses
| Example | Regression model | Analysis (dependent variable ~ independent variable[s]) | Classification per number of independent variable(s) | Classification per number of outcomes/dependent variables |
|---|---|---|---|---|
| 1a | Logistic regression | AE occurrence ~ C max | Univariable | Univariate |
| 1b | AE occurrence ~ C max, age, race, cotherapy | Multivariable | Univariate | |
| 1c | Longitudinal logistic regression | AE occurrence over time ~ C max preceding AE event (longitudinal) | Univariable | Multivariate |
| 1d | AE occurrence over time ~ C max preceding AE event (longitudinal), age, race, cotherapy | Multivariable | Multivariate | |
| 2a | Logistic regression | BOR ~ C min | Univariable | Univariate |
| 2b | BOR ~ C min, tumor size, performance status | Multivariable | Univariate | |
| 2c | Longitudinal logistic regression | Response status over time ~ C min | Univariable | Multivariate |
| 2d | Response status over time ~ C min, tumor size, performance status | Multivariable | Multivariate | |
| 3a | Parametric TTE | PFS ~ C min | Univariable | Univariate |
| 3b | PFS ~ C min, number of nontarget lesions, smoking status | Multivariable | Univariate | |
| 3c | Parametric repeated TTE | Occurrence of relapses in multiple sclerosis ~ model‐predicted absolute lymphocyte count | Univariable | Multivariate |
| 3d | Occurrence of relapses in multiple sclerosis ~ model‐predicted absolute lymphocyte count, age | Multivariable | Multivariate | |
| 4a | Parametric TTE | OS ~ C min | Univariable | Univariate |
| 4b | OS ~ C min, tumor size, neutrophil‐to‐lymphocyte ratio | Multivariable | Univariate | |
| 5a | NLME | Plasma glucose and HbA1c ~ drug concentration over time | Univariable | Multivariate |
| 5b | Plasma glucose and HbA1c ~ drug concentration over time, anemia | Multivariable | Multivariate | |
| 6a | Linear or nonlinear regression | Change in tumor size from baseline at Week X ~ C min | Univariable | Univariate |
| 6b | Change in tumor size from baseline at Week X ~ C min, body weight, performance status | Multivariable | Univariate |
Abbreviations: AE, adverse event; BOR, best overall response; C max, maximum drug concentration; Cmin, minimum drug concentration; HbA1c, hemoglobin A1c; NLME, nonlinear mixed effects; OS, overall survival; PFS, progression‐free survival; TTE, time to event.