dst01_3.RdThe DST01_3 Disposition Table provides an overview of patients study treatment status. For patients who discontinued the study, the reason provided is categorized as "Safety" or "Non-Safety" issue.
dst01_3(
adam_db,
armvar = .study$planarm,
status = .study$status_var,
disc_reason_var = .study$disc_reason_var,
status_treatment = "EOTSTT",
lbl_overall = .study$lbl_overall,
prune_0 = TRUE,
deco = std_deco("DST01"),
.study = list(planarm = "ARM", disc_reason_var = "DCSREAS", lbl_overall =
"All Patients", status_var = "EOSSTT")
)
dst01_3_lyt(
armvar = .study$planarm,
status_treatment = .study$status,
completed_lbl = "COMPLETED",
discontinued_lbl = "DISCONTINUED",
ongoing_lbl = "ONGOING",
lbl_overall = .study$lbl_overall,
deco = std_deco("DST01"),
.study = list(planarm = "ARM", lbl_overall = "All Patients", status_treatment =
"EOTSTT")
)
dst01_3_pre(
adam_db,
reason = .study$disc_reason_var,
.study = list(disc_reason_var = "DCSREAS")
)(dm) object containing the ADaM datasets
(character) variable used for column splitting
(character) variable used to define patient status. Default is EOSSTT, however can also be a
variable name with the pattern EOPxxSTT where xx must be substituted by 2 digits referring to the analysis
period.
(character) variable used to define reason for patient withdrawal. Default is DCSREAS,
however can also be a variable with the pattern DCPxxRS where xx must be substituted by 2 digits referring to
the analysis period.
(string) variable used to define the treatment status of the patients. Default is EOTSTT,
however can also be a variable with the pattern EOTxxSTT where xx must be substituted by 2 digits referring to
the analysis period.
(character) label used for overall column, if set to NULL the overall column is omitted
(logical) remove 0 count rows
(character) decoration with title, subtitles and main_footer content
(list) with default values for the arguments of the function
(string) associated with completed treatment and found in the columns given by
status_treatment. By Default COMPLETED.
(string) associated with discontinued treatment and found in the columns given by
status_treatment. By Default DISCONTINUED.
(string) associated with ongoing treatment and found in the columns given by status_treatment.
By Default `ONGOING.
(character) the variable name for variable with the reason for discontinuation.
Non-standard disposition table summarizing the reasons for patient withdrawal and treatment status.
Withdrawal reasons are grouped into Safety and Non-Safety issues.
Safety issues include Death and Adverse Events.
Numbers represent absolute numbers of patients and fraction of N.
Remove zero-count rows.
Split columns by arm.
Include a total column by default.
Sort withdrawal reasons by alphabetic order.
dst01_3_lyt: dst01_3 Layout
dst01_3_pre: dst01_3 Preprocessing
library(dm)
db <- syn_test_data() %>%
dst01_3_pre()
dst01_3(db)
#> Patient Disposition: {Analysis Population}
#> Protocol: {{protocol}}
#>
#> ———————————————————————————————————————————————————————————————————————————————————————————
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> ———————————————————————————————————————————————————————————————————————————————————————————
#> Completed Study 69 (51.5%) 69 (51.5%) 72 (54.5%) 210 (52.5%)
#> Ongoing 27 (20.1%) 22 (16.4%) 21 (15.9%) 70 (17.5%)
#> Discontinued Study 38 (28.4%) 43 (32.1%) 39 (29.5%) 120 (30.0%)
#> Safety 28 (20.9%) 27 (20.1%) 21 (15.9%) 76 (19.0%)
#> ADVERSE EVENT 6 (4.5%) 1 (0.7%) 2 (1.5%) 9 (2.2%)
#> DEATH 22 (16.4%) 26 (19.4%) 19 (14.4%) 67 (16.8%)
#> Non-safety 10 (7.5%) 16 (11.9%) 18 (13.6%) 44 (11.0%)
#> LACK OF EFFICACY 2 (1.5%) 1 (0.7%) 2 (1.5%) 5 (1.2%)
#> PHYSICIAN DECISION 0 1 (0.7%) 7 (5.3%) 8 (2%)
#> PROTOCOL VIOLATION 4 (3%) 7 (5.2%) 6 (4.5%) 17 (4.2%)
#> WITHDRAWAL BY PARENT/GUARDIAN 2 (1.5%) 5 (3.7%) 3 (2.3%) 10 (2.5%)
#> WITHDRAWAL BY SUBJECT 2 (1.5%) 2 (1.5%) 0 4 (1%)
#> Completed Treatment 53 (39.6%) 39 (29.1%) 48 (36.4%) 140 (35.0%)
#> Ongoing Treatment 44 (32.8%) 46 (34.3%) 40 (30.3%) 130 (32.5%)
#> Discontinued Treatment 37 (27.6%) 49 (36.6%) 44 (33.3%) 130 (32.5%)
dst01_3(db, lbl_overall = NULL)
#> Patient Disposition: {Analysis Population}
#> Protocol: {{protocol}}
#>
#> ————————————————————————————————————————————————————————————————————————————
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————
#> Completed Study 69 (51.5%) 69 (51.5%) 72 (54.5%)
#> Ongoing 27 (20.1%) 22 (16.4%) 21 (15.9%)
#> Discontinued Study 38 (28.4%) 43 (32.1%) 39 (29.5%)
#> Safety 28 (20.9%) 27 (20.1%) 21 (15.9%)
#> ADVERSE EVENT 6 (4.5%) 1 (0.7%) 2 (1.5%)
#> DEATH 22 (16.4%) 26 (19.4%) 19 (14.4%)
#> Non-safety 10 (7.5%) 16 (11.9%) 18 (13.6%)
#> LACK OF EFFICACY 2 (1.5%) 1 (0.7%) 2 (1.5%)
#> PHYSICIAN DECISION 0 1 (0.7%) 7 (5.3%)
#> PROTOCOL VIOLATION 4 (3%) 7 (5.2%) 6 (4.5%)
#> WITHDRAWAL BY PARENT/GUARDIAN 2 (1.5%) 5 (3.7%) 3 (2.3%)
#> WITHDRAWAL BY SUBJECT 2 (1.5%) 2 (1.5%) 0
#> Completed Treatment 53 (39.6%) 39 (29.1%) 48 (36.4%)
#> Ongoing Treatment 44 (32.8%) 46 (34.3%) 40 (30.3%)
#> Discontinued Treatment 37 (27.6%) 49 (36.6%) 44 (33.3%)
dst01_3_lyt(
armvar = "ACTARM",
status_treatment = "EOTxx01"
)
syn_test_data() %>%
dst01_3_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 847
#> Primary keys: 2
#> Foreign keys: 1