FMQ (Broad) A: Drug X B: Placebo C: Combination Risk Difference (%) (95% CI)
Preferred Term (N=134) (N=134) (N=132) (N=268)
—————————————————————————————————————————————————————————————————————————————————————————————
Erectile Dysfunction
dcd B.2.2.3.1 11 (8.2%) 12 (9.0%) 14 (10.6%) 0.7 (-6.0 - 7.5)
dcd C.1.1.1.3 7 (5.2%) 5 (3.7%) 7 (5.3%) -1.5 (-6.4 - 3.5)
Gynecomastia
dcd B.2.2.3.1 10 (7.5%) 16 (11.9%) 15 (11.4%) 4.5 (-2.6 - 11.5)
dcd C.1.1.1.3 7 (5.2%) 6 (4.5%) 10 (7.6%) -0.7 (-5.9 - 4.4)
FDA Table 16
Patients With Adverse Events by Male-Specific FDA Medical Query (Broad) and Preferred Term, Male Safety Population, Pooled Analyses
# Load Libraries & Data
library(falcon)
adsl <- random.cdisc.data::cadsl
adae <- random.cdisc.data::cadae
# Pre-Processing - Ensure required variables FMQ01SC and FMQ01NAM exist in adae
set.seed(1)
adae <- dplyr::rename(adae, FMQ01SC = SMQ01SC, FMQ01NAM = SMQ01NAM)
levels(adae$FMQ01SC) <- c("BROAD", "NARROW")
adae$FMQ01SC[is.na(adae$FMQ01SC)] <- "NARROW"
adae$FMQ01NAM <- factor(adae$FMQ01NAM, levels = c(unique(adae$FMQ01NAM), "Erectile Dysfunction", "Gynecomastia"))
adae$FMQ01NAM[adae$SEX == "M"] <- as.factor(
sample(c("Erectile Dysfunction", "Gynecomastia"), sum(adae$SEX == "M"), replace = TRUE)
)
# Output Table
risk_diff <- list(arm_x = "B: Placebo", arm_y = "A: Drug X")
make_table_16(adae = adae, alt_counts_df = adsl, risk_diff = risk_diff)
make_table_16()
Required variables:
-
adae
:adae
must containUSUBJID
,SEX
, and the variables specified byarm_var
,saffl_var
,pref_var
,fmqsc_var
andfmqnam_var
. -
alt_counts_df
(if specified):USUBJID
and the variables specified byarm_var
andsaffl_var
.
Argument | Description | Default |
---|---|---|
adae |
(data.frame ) Dataset (typically ADAE) required to build table. |
No default |
alt_counts_df |
(character ) Alternative dataset used only to calculate column counts. |
NULL |
show_colcounts |
(flag ) Whether column counts should be printed. |
TRUE |
arm_var |
(character ) Arm variable used to split table into columns. |
"ARM" |
saffl_var |
(character ) Flag variable used to indicate inclusion in safety population. |
"SAFFL" |
pref_var |
(character ) Preferred term variable to use in table. |
"AEDECOD" |
sex_scope |
(character ) Level of SEX to output in table. |
"M" |
fmq_scope |
(character ) FMQ scope value to use in table. |
"BROAD" |
fmqsc_var |
(character ) FMQ scope variable to use in table. |
"FMQ01SC" |
fmqnam_var |
(character ) FMQ reference name variable to use in table. |
"FMQ01NAM" |
lbl_overall |
(character ) If specified, an overall column will be added to the table with the given value as the column label. |
NULL |
risk_diff |
(named
|
NULL |
prune_0 |
(flag ) Whether all-zero rows should be removed from the table. |
FALSE |
na_level |
(character ) String to represent missing values. |
"<Missing>" |
annotations |
(named list of character ) List of annotations to add to the table. Valid annotation types are title , subtitles , main_footer , and prov_footer . Each name-value pair should use the annotation type as name and the desired string as value. |
NULL |
Source code for this function is available here.