A: Drug X B: Placebo C: Combination Risk Difference (%) (95% CI)
Parameter (N=134) (N=134) (N=132) (N=268)
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Duration of Treatment, days
Mean (SD) 961.49 (208.62) 949.45 (223.73) 984.71 (200.08) NA
Median (min - max) 1095.75 (392.79 - 1095.75) 1095.75 (387.34 - 1095.75) 1095.75 (368.91 - 1095.75) NA
Interquartile range 859.95 - 1095.75 781.56 - 1095.75 960.34 - 1095.75 NA
Total exposure (person years) 105763.56 (289.56) 100641.30 (275.54) 109302.29 (299.25) NA
Patients Treated, by duration
Any duration (at least 1 dose) 110 (82.1%) 106 (79.1%) 111 (84.1%) -3.0 (-12.4 - 6.5)
<1 month 0 0 0 0.0 (0.0 - 0.0)
>=1 month 110 (82.1%) 106 (79.1%) 111 (84.1%) -3.0 (-12.4 - 6.5)
>=3 months 110 (82.1%) 106 (79.1%) 111 (84.1%) -3.0 (-12.4 - 6.5)
>=6 months 110 (82.1%) 106 (79.1%) 111 (84.1%) -3.0 (-12.4 - 6.5)
>=12 months 110 (82.1%) 106 (79.1%) 111 (84.1%) -3.0 (-12.4 - 6.5)
FDA Table 5
Duration of Treatment Exposure, Safety Population, Pooled Analyses
make_table_05()
Required variables:
-
df
: The variables specified byvars
,arm_var
, andsaffl_var
. -
alt_counts_df
(if specified):USUBJID
and the variables specified byarm_var
andsaffl_var
.
Argument | Description | Default |
---|---|---|
df |
(data.frame ) Dataset (typically ADSL) required to build table. |
No default |
alt_counts_df |
(character ) Alternative dataset used only to calculate column counts. |
NULL |
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" |
id_var |
(character ) Identifier variable used to count the participants within each flag. |
"USUBJID" |
trtsdtm_var |
(character ) Treatment start datetime variable in df. |
"TRTSDTM" |
trtedtm_var |
(character ) Treatment end datetime variable in df. |
"TRTEDTM" |
u_trtdur |
(character ) Unit for duration of treatment. Options are "days" , "weeks" , "months" and "years" . |
"days" |
lbl_trtdur |
(character ) Label for treatment duration variable u_trtdur . |
paste("Duration of Treatment,", u_trtdur) |
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. |
TRUE |
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.