A: Drug X B: Placebo C: Combination Risk Difference (%) (95% CI)
Primary System Organ Class (N=134) (N=134) (N=132) (N=268)
————————————————————————————————————————————————————————————————————————————————————————————————————
cl A 78 (58.2%) 75 (56.0%) 89 (67.4%) -2.2 (-14.1 - 9.6)
dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%) -3.7 (-15.2 - 7.7)
dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%) 0.0 (-11.5 - 11.5)
dcd B.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.2.3.1 0 0 0 0.0 (0.0 - 0.0)
dcd C.1.1.1.3 0 0 0 0.0 (0.0 - 0.0)
dcd C.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.4.2 0 0 0 0.0 (0.0 - 0.0)
dcd D.2.1.5.3 0 0 0 0.0 (0.0 - 0.0)
cl B 96 (71.6%) 89 (66.4%) 97 (73.5%) -5.2 (-16.3 - 5.8)
dcd A.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd A.1.1.1.2 0 0 0 0.0 (0.0 - 0.0)
dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%) 1.5 (-10.0 - 13.0)
dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%) -3.7 (-15.1 - 7.7)
dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%) 4.5 (-7.1 - 16.1)
dcd C.1.1.1.3 0 0 0 0.0 (0.0 - 0.0)
dcd C.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.4.2 0 0 0 0.0 (0.0 - 0.0)
dcd D.2.1.5.3 0 0 0 0.0 (0.0 - 0.0)
cl C 67 (50.0%) 75 (56.0%) 79 (59.8%) 6.0 (-6.0 - 17.9)
dcd A.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd A.1.1.1.2 0 0 0 0.0 (0.0 - 0.0)
dcd B.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.2.3.1 0 0 0 0.0 (0.0 - 0.0)
dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%) 2.2 (-9.0 - 13.5)
dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%) 9.7 (-1.3 - 20.7)
dcd D.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.4.2 0 0 0 0.0 (0.0 - 0.0)
dcd D.2.1.5.3 0 0 0 0.0 (0.0 - 0.0)
cl D 96 (71.6%) 90 (67.2%) 98 (74.2%) -4.5 (-15.5 - 6.5)
dcd A.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd A.1.1.1.2 0 0 0 0.0 (0.0 - 0.0)
dcd B.1.1.1.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd B.2.2.3.1 0 0 0 0.0 (0.0 - 0.0)
dcd C.1.1.1.3 0 0 0 0.0 (0.0 - 0.0)
dcd C.2.1.2.1 0 0 0 0.0 (0.0 - 0.0)
dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%) -6.0 (-17.3 - 5.4)
dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%) -4.5 (-15.8 - 6.8)
dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%) 8.2 (-3.4 - 19.9)
FDA Table 36
Patients With Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
make_table_36()
Required variables:
-
adae
: The variables specified byid_var
,arm_var
,saffl_var
,soc_var
, andpref_var
. -
alt_counts_df
(if specified): The variables specified byid_var
,arm_var
, andsaffl_var
.
Argument | Description | Default |
---|---|---|
adae |
(data.frame ) Dataset (typically ADAE) required to build table. |
No default |
alt_counts_df |
(character ) Alternative dataset (typically ADSL) 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" |
soc_var |
(character ) SOC variable from adae to include in the table. |
"AESOC" |
pref_var |
(character ) Preferred term variable from adae to include in the table. |
"AEDECOD" |
lbl_soc_var |
(character ) Label corresponding to SOC variable soc_var to print in the table. |
formatters::var_labels(adae, fill = TRUE)[soc_var] |
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 |
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.