@@ -94,12 +94,20 @@ We then define the related population (`population = "apat"`) and observation (`
9494``` {r}
9595meta <- meta |>
9696 define_population(
97- name = "apat", group = "TRTA", id = "USUBJID",
98- subset = SAFFL == "Y", label = "All Patient as Treated"
97+ name = "apat",
98+ group = "TRTA",
99+ id = "USUBJID",
100+ subset = SAFFL == "Y",
101+ label = "All Patient as Treated",
102+ var = c("USUBJID", "SAFFL", "TRTA", "SITEID", "SEX", "RACE", "AGE")
99103 ) |>
100104 define_observation(
101- name = "apat", group = "TRTA",
102- subset = SAFFL == "Y", label = "All Patient as Treated"
105+ name = "apat",
106+ group = "TRTA",
107+ subset = SAFFL == "Y",
108+ label = "All Patient as Treated",
109+ var = c("USUBJID", "SAFFL", "TRTA", "AEDECOD", "AEBODSYS",
110+ "AEREL", "AESER", "AEOUT", "AEACN", "AESDTH", "ASTDT", "AENDT")
103111 )
104112```
105113
@@ -110,17 +118,19 @@ meta <- meta |>
110118 name = "any",
111119 subset = NULL,
112120 label = "Any AEs",
113- var = "AEDECOD", soc = "AEBODSYS"
121+ var = "AEDECOD",
122+ soc = "AEBODSYS"
114123 )
115124```
116125For drug related AEs (` "drug-related" ` ), its filter is ` AEREL %in% c("PROBABLE", "POSSIBLE") ` .
117126``` {r}
118127meta <- meta |>
119128 define_parameter(
120129 name = "drug-related",
121- subset = toupper(AREL) == "RELATED" ,
130+ subset = toupper(AEREL) %in% c("PROBABLE", "POSSIBLE") ,
122131 label = "Drug-related AEs",
123- var = "AEDECOD", soc = "AEBODSYS"
132+ var = "AEDECOD",
133+ soc = "AEBODSYS"
124134 )
125135```
126136Similarly, we define serious AE and drug related serious AEs.
@@ -130,13 +140,15 @@ meta <- meta |>
130140 name = "serious",
131141 subset = AESER == "Y",
132142 label = "Serious AEs",
133- var = "AEDECOD", soc = "AEBODSYS"
143+ var = "AEDECOD",
144+ soc = "AEBODSYS"
134145 ) |>
135146 define_parameter(
136147 name = "drug-related-serious",
137- subset = AESER == "Y" & AEREL %in% c("PROBABLE", "POSSIBLE"),
148+ subset = AESER == "Y" & toupper( AEREL) %in% c("PROBABLE", "POSSIBLE"),
138149 label = "Drug-related serious AEs",
139- var = "AEDECOD", soc = "AEBODSYS"
150+ var = "AEDECOD",
151+ soc = "AEBODSYS"
140152 )
141153```
142154
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