MHT01 Table 1 (Default) Medical History Table 1mht01_1.RdThe MHT01 table provides an overview of the subjects medical history by SOC and Preferred Term.
mht01_1(
adam_db,
armvar = .study$planarm,
lbl_overall = .study$lbl_overall,
lbl_mhbodsys = var_labels_for(adam_db$admh, "MHBODSYS"),
lbl_mhdecod = var_labels_for(adam_db$admh, "MHDECOD"),
prune_0 = TRUE,
deco = std_deco("MHT01"),
.study = list(planarm = "ARM", lbl_overall = NULL)
)
mht01_1_lyt(
armvar = .study$planarm,
lbl_overall = .study$lbl_overall,
lbl_mhbodsys = "MedDRA System Organ Class",
lbl_mhdecod = "MedDRA preferred Term",
deco = std_deco("MHT01"),
.study = list(planarm = "ARM", lbl_overall = NULL)
)
mht01_1_pre(adam_db)(dm) object containing the ADaM datasets
(character) variable used for column splitting
(character) label used for overall column, if set to NULL the overall column is omitted
(character) text label for MHBODSYS.
(character) text label for MHDECOD.
(logical) remove 0 count rows
(character) decoration with title, subtitles and main_footer content
(list) with default values for the arguments of the function
Numbers represent absolute numbers of patients and fraction of N, or absolute number of event when specified.
Remove zero-count rows unless overridden with prune_0 = FALSE.
Split columns by arm.
Does not include a total column by default.
Order by body system alphabetically and within body system and medical condition by decreasing total number of patients with the specific condition.
mht01_1_lyt: mht01_1 Layout
mht01_1_pre: mht01_1 Preprocessing
library(dm)
db <- syn_test_data() %>%
mht01_1_pre()
mht01_1(adam_db = db) %>% head(15)
#> Medical History: {Specify Population}
#> Protocol: {{protocol}}
#>
#> ——————————————————————————————————————————————————————————————————————————————————————————————————
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one condition 122 (91%) 123 (91.8%) 120 (90.9%)
#> Total number of conditions 609 622 703
#> cl A
#> Total number of patients with at least one condition 78 (58.2%) 75 (56%) 89 (67.4%)
#> Total number of conditions 132 130 160
#> trm A_1/2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> trm A_2/2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B
#> Total number of patients with at least one condition 96 (71.6%) 89 (66.4%) 97 (73.5%)
#> Total number of conditions 185 198 205
#> trm B_3/3 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> trm B_2/3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> trm B_1/3 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C
#> Total number of patients with at least one condition 67 (50%) 75 (56%) 79 (59.8%)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————
#>
#> Investigator text for medical history conditions coded using MedDRA version xx.x. Percentages are based on N in the column headings.
#> Provide study specific footnote that describes exactly what the diseases and conditions are included (e.g., includes diseases and conditions present within 6 months of screening, as reported by the patient).
#>
mht01_1_lyt(
armvar = "ACTARM",
lbl_overall = NULL,
deco = std_deco("MHT01")
)
#> A Pre-data Table Layout
#>
#> Column-Split Structure:
#> ACTARM (lvls)
#>
#> Row-Split Structure:
#> MHBODSYS (lvls) -> MHDECOD (** analysis **)
#>
syn_test_data() %>%
mht01_1_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1