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Generate an Adverse Event table

Source: R/data.R
example_ae.Rd

Generate an Adverse Event table

Usage

example_ae(
  enrolres,
  p_na = 0,
  p_sae = 0.1,
  p_sae_trt = p_sae,
  n_max = 15,
  n_max_trt = n_max,
  w_soc = 1,
  w_soc_trt = 1,
  beta0 = -1,
  beta_trt = 0.4,
  beta_sae = 1
)

Arguments

enrolres

the enrolment result table, from .example_enrol

p_na

proportion of missing values (can be a list with a value for each column)

p_sae, p_sae_trt

proportion of serious AE in control/exp arms

n_max, n_max_trt

maximum number of AE per patient in control/exp arms (binomial with probability 20%)

w_soc, w_soc_trt

log-weights for SOC that should be over-representated in control/exp arms.

beta0, beta_trt, beta_sae

the intercept, treatement coef and SAE coef to be used in the exponential decay model that generates the AE grade.

Columns

  • subjid: the patient identifier. Each patient has a number of AE simulated with a binomial distribution with size n_max or n_max_trt and probability 20%.

  • aesoc: the CTCAE System Organ Class. Lazily simulated with an uniform probability.

  • aeterm: the CTCAE High Level Group Term. Lazily simulated with an uniform probability. Four examples of HLGT per SOC are provided.

  • aegr: the CTCAE grade, ranging from 1 to 5. The probability is simulated using an exponential decay rate for grades 1 to 4 (probs = exp(rate * c(1:4))), with probability for grade 5 being the one for grade 4 divided by 7. The probability vector is then normalized to sum to 1. The rate is calculated as rate = beta0 + beta_trt*(arm!="Control") + beta_sae*(sae=="Yes").

  • aerel: the causality of the AE. Lazily simulated with an uniform probability.

  • sae: Indicator of Serious AE. Simulated using p_sae and p_sae_trt.