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An S7 class for representing clinical study endpoints. Replaces the previous PrimaryEndpoint, SecondaryEndpoint, and SafetyEndpoint classes with a unified class using the category property.

Usage

Endpoint(
  name = character(0),
  variable = character(0),
  type = "continuous",
  category = "primary",
  description = NULL,
  hypothesis = "superiority",
  margin = NULL,
  alpha = 0.05,
  priority = 1,
  metadata = list()
)

Arguments

name

Character string for endpoint name

variable

Character string for variable name in the dataset

type

Character string for endpoint type: "continuous", "binary", "tte", "count", "pro"

category

Character string for endpoint category: "primary", "secondary", "safety", "exploratory"

description

Character string for endpoint description

hypothesis

Character string for hypothesis type: "superiority", "non-inferiority", "equivalence"

margin

Numeric value for non-inferiority/equivalence margin (if applicable)

alpha

Numeric value for significance level (default: 0.05)

priority

Numeric value for analysis priority (default: 1)

metadata

List of additional metadata

Value

An Endpoint object

Examples

if (FALSE) { # \dontrun{
# Primary efficacy endpoint
endpoint <- Endpoint(
  name = "Overall Survival",
  variable = "AVAL",
  type = "tte",
  category = "primary",
  hypothesis = "superiority"
)

# Safety endpoint
ae_endpoint <- Endpoint(
  name = "Treatment-Emergent AEs",
  variable = "AETERM",
  type = "count",
  category = "safety"
)
} # }