Time to Event Analysis Dataset (ADTTE)

Synthetic CDISC ADaM Time-to-Event (ADTTE) dataset from study TFRM-2024-001. Contains one row per subject per time-to-event parameter. Used for:

• Time to event table (Table 14.2.1): Kaplan-Meier estimates, median time-to-event, and hazard ratios by treatment arm

Two parameters are included:

• "TTWD" — Time to Study Withdrawal (event = discontinued, censored = completed)

• "TTAE" — Time to First Adverse Event (event = first AE, censored = no AE)

Usage

adtte

Format

A data frame with 270 rows (135 subjects x 2 parameters) and 16 variables:

STUDYID

Study identifier

USUBJID

Unique subject identifier

ARM

Planned treatment arm

TRTA

Actual treatment arm

TRTAN

Actual treatment numeric code

AGE

Subject age

SEX

Subject sex

SAFFL

Safety population flag

ITTFL

Intent-to-treat population flag

PARAMCD

Parameter code: "TTWD" or "TTAE"

PARAM

Parameter label: "Time to Study Withdrawal (Days)" or "Time to First Adverse Event (Days)"

AVAL

Analysis value — time in days from treatment start to event or censoring

CNSR

Censoring indicator: 0 = event occurred, 1 = censored

STARTDT

Treatment start date (used as reference/origin date)

ADT

Date of event or censoring

ADY

Relative day of event or censoring

Source

Synthetic data generated in data-raw/create_adam_datasets.R.

Examples

# Subset to one parameter
ttwd <- subset(adtte, PARAMCD == "TTWD")
table(ttwd$ARM, ttwd$CNSR)  # 0 = withdrew, 1 = completed
#>                 
#>                   0  1
#>   Placebo         1 44
#>   Zomerane 100mg  8 37
#>   Zomerane 50mg   4 41

# Median time to first AE by arm (unadjusted)
ttae <- subset(adtte, PARAMCD == "TTAE")
tapply(ttae$AVAL, ttae$ARM, median)
#>        Placebo Zomerane 100mg  Zomerane 50mg 
#>             24             13             16