Skip to contents

Time-to-Event Summary Table (Table 14.2.1.1)

Source: R/data.R
tbl_tte.Rd

Pre-summarized time-to-withdrawal table matching the pharma reference shell for Kaplan-Meier survival analysis output. Includes four sections:

  • Event counts: events and censored n (%) per arm

  • KM percentile estimates: 25th percentile, median, 75th percentile with 95% confidence intervals

  • Log-rank test: two-sided p-value

  • Hazard ratios: active vs placebo with 95% CI

KM estimates and hazard ratios are pre-computed synthetic values (no survival package dependency). Values are realistic for a 24-week trial with low event rates.

Usage

tbl_tte

Format

A data frame with 12 rows and 5 columns:

section

Section grouping key: "Time to Study Withdrawal", "KM Estimates", "Log-Rank Test", or "Hazard Ratio". Use with fr_rows(group_by = "section") for visual separation between blocks

statistic

Row label with indentation (e.g. " Median (95% CI) [a]", " Zom 50mg vs Placebo"). Section headers have no indent; detail rows are indented with two spaces

zom_50mg

Zomerane 50mg arm value

zom_100mg

Zomerane 100mg arm value

placebo

Placebo arm value

Source

Synthetic data generated in data-raw/create_tbl_datasets.R from adtte (TTWD parameter).

Examples

tbl_tte
#>                     section                       statistic
#> 1  Time to Study Withdrawal        Time to Study Withdrawal
#> 2  Time to Study Withdrawal                   Events, n (%)
#> 3  Time to Study Withdrawal                 Censored, n (%)
#> 4              KM Estimates Time to Study Withdrawal (Days)
#> 5              KM Estimates    25th Percentile (95% CI) [a]
#> 6              KM Estimates             Median (95% CI) [a]
#> 7              KM Estimates    75th Percentile (95% CI) [a]
#> 8             Log-Rank Test                   Log-Rank Test
#> 9             Log-Rank Test           Two-sided p-value [b]
#> 10             Hazard Ratio       Hazard Ratio (95% CI) [c]
#> 11             Hazard Ratio             Zom 50mg vs Placebo
#> 12             Hazard Ratio            Zom 100mg vs Placebo
#>                zom_50mg            zom_100mg     placebo
#> 1                                                       
#> 2               4 (8.9)             8 (17.8)     1 (2.2)
#> 3             41 (91.1)            37 (82.2)   44 (97.8)
#> 4                                                       
#> 5  168.0 (152.4, 183.6) 168.0 (157.0, 179.0) NE (NE, NE)
#> 6  168.0 (155.0, 181.0) 168.0 (158.8, 177.2) NE (NE, NE)
#> 7           NE (NE, NE)          NE (NE, NE) NE (NE, NE)
#> 8                                                       
#> 9                 0.287                                 
#> 10                                                      
#> 11 1.520 (0.650, 3.570)                                 
#> 12                      2.140 (0.970, 4.700)            

# Render with section grouping and footnotes
spec <- tbl_tte |>
  fr_table() |>
  fr_cols(
    section   = fr_col(visible = FALSE),
    statistic = fr_col("", width = 3),
    zom_50mg  = fr_col("Zomerane 50mg"),
    zom_100mg = fr_col("Zomerane 100mg"),
    placebo   = fr_col("Placebo")
  ) |>
  fr_rows(group_by = "section") |>
  fr_footnotes(
    "[a] Kaplan-Meier estimate.",
    "[b] Two-sided log-rank test.",
    "[c] Cox proportional hazards model."
  )