simHCE | R Documentation |

`hce`

object with given event rates of time-to-event outcomes (Weibull), mean and SD of the continuous outcome (normal or log-normal) by treatment groupSimulate `hce`

object with given event rates of time-to-event outcomes (Weibull), mean and SD of the continuous outcome (normal or log-normal) by treatment group

```
simHCE(
n,
n0 = n,
TTE_A,
TTE_P,
CM_A,
CM_P,
CSD_A = 1,
CSD_P = 1,
fixedfy = 1,
yeardays = 360,
pat = 100,
shape = 1,
logC = FALSE,
seed = NULL
)
```

`n` |
sample size in the active treatment group. |

`n0` |
sample size in the placebo group. |

`TTE_A` |
event rates per year in the active group for the time-to-event outcomes. |

`TTE_P` |
event rates per year in the placebo group for the time-to-event outcomes. Should have the same length as |

`CM_A` |
mean value for the continuous outcome of the active group. |

`CM_P` |
mean value for the continuous outcome of the placebo group. |

`CSD_A` |
standard deviation for the continuous outcome of the active group. |

`CSD_P` |
standard deviation for the continuous outcome of the placebo group. |

`fixedfy` |
length of follow-up in years. |

`yeardays` |
number of days in a year. |

`pat` |
scale of provided event rates (per |

`shape` |
shape of the Weibull distribution for time-to-event outcomes. Default is exponential distribution with |

`logC` |
logical, whether to use log-normal distribution for the continuous outcome. |

`seed` |
the seed for generating random numbers. |

an object of class `hce`

containing the following columns:

ID subject identifier.

TRTP planned treatment group - "A" for active, "P" for Placebo.

GROUP type of the outcome, either "TTE" for time-to-event outcomes or "C" for continuous. Only one continuous outcome is possible, but no restriction on the number of "TTE" outcomes.

GROUPN order of outcomes in

`GROUP`

, with a higher value signifying a better outcome.AVALT the timing of the time-to-event outcomes.

AVAL0 numeric values of the continuous outcome and the timing of "TTE" outcomes.

AVAL analysis values derived as

`AVAL0 + GROUPN`

. For the continuous outcome the values of`AVAL0`

are shifted to start always from 0.seed the seed of the random sample. If not specified in

`seed`

argument will be selected based on system time.PADY primary analysis day, the length of fixed follow-up in days calculated as

`yeardays`

multiplied by`fixedfy`

.

`hce()`

, `as_hce()`

for the helper a coerce function to hce objects.

```
# Example 1
Rates_A <- c(1.72, 1.74, 0.58, 1.5, 1)
Rates_P <- c(2.47, 2.24, 2.9, 4, 6)
dat <- simHCE(n = 2500, TTE_A = Rates_A, TTE_P = Rates_P,
CM_A = -3, CM_P = -6, CSD_A = 16, CSD_P = 15, fixedfy = 3)
head(dat)
# Example 2
Rates_A <- 10
Rates_P <- 15
dat <- simHCE(n = 1000, n0 = 500, TTE_A = Rates_A, TTE_P = Rates_P,
CM_A = 0.1, CM_P = 0, seed = 5, shape = 0.2, logC = TRUE)
summaryWO(dat)
```

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