ae <- read.csv("data/ae.csv")
dm <- read.csv("data/dm.csv")
big_n_df <- dm %>%
filter(ARMCD == "BLINDED") %>%
select(USUBJID, strata = ARMCD) %>%
distinct()
events
ae_trt <- ae %>%
filter(EPOCH == "TREATMENT") %>%
sample_n(15)
# tbl_ae_count_ex1 <-
tbl_ae_count(
data = ae_trt,
ae = AEDECOD,
soc = AESOC,
strata = EPOCH,
by = AESEV
) %>%
add_overall(across = "overall-only")
| Adverse Event |
TREATMENT
|
Overall |
| MILD |
MODERATE |
| 10017947 |
2 |
— |
2 |
| Diarrhoea |
1 |
— |
1 |
| Epigastric discomfort |
1 |
— |
1 |
| 10018065 |
1 |
1 |
2 |
| Fatigue |
1 |
1 |
2 |
| 10022117 |
1 |
— |
1 |
| Fall |
1 |
— |
1 |
| 10022891 |
1 |
— |
1 |
| SARS-CoV-2 test positive |
1 |
— |
1 |
| 10029205 |
3 |
2 |
5 |
| Dysgeusia |
1 |
— |
1 |
| Dystonia |
1 |
— |
1 |
| Headache |
1 |
2 |
3 |
| 10037175 |
3 |
— |
3 |
| Anxiety |
1 |
— |
1 |
| Insomnia |
1 |
— |
1 |
| Mood swings |
1 |
— |
1 |
| 10047065 |
1 |
— |
1 |
| Orthostatic hypotension |
1 |
— |
1 |
# modify_header(all_ae_cols() ~ "**Grade {by}**")
subjects
# tbl_ae_ex2 <-
ae %>%
filter(AESEV %in% c("MILD", "MODERATE", "SEVERE")) %>%
sample_n(15) %>%
tbl_ae(
id = USUBJID,
# id_df = big_n_df,
ae = AEDECOD,
soc = AESOC,
by = AESEV
) %>%
add_overall()
| Adverse Event |
N = 14
|
| MILD |
MODERATE |
Overall |
| 10007541 |
— |
1 (7.1) |
1 (7.1) |
| Angina unstable |
— |
1 (7.1) |
1 (7.1) |
| 10017947 |
2 (14) |
1 (7.1) |
3 (21) |
| Nausea |
2 (14) |
1 (7.1) |
3 (21) |
| 10018065 |
1 (7.1) |
1 (7.1) |
2 (14) |
| Oedema peripheral |
1 (7.1) |
1 (7.1) |
2 (14) |
| 10021881 |
4 (29) |
— |
4 (29) |
| Bacteriuria |
1 (7.1) |
— |
1 (7.1) |
| COVID-19 |
1 (7.1) |
— |
1 (7.1) |
| Gastroenteritis viral |
1 (7.1) |
— |
1 (7.1) |
| Viral infection |
1 (7.1) |
— |
1 (7.1) |
| 10029205 |
2 (14) |
2 (14) |
4 (29) |
| Dizziness |
1 (7.1) |
1 (7.1) |
2 (14) |
| Motor dysfunction |
— |
1 (7.1) |
1 (7.1) |
| Syncope |
1 (7.1) |
— |
1 (7.1) |
| 10038738 |
1 (7.1) |
— |
1 (7.1) |
| Hyperventilation |
1 (7.1) |
— |
1 (7.1) |
# %>%
# modify_header(all_ae_cols() ~ "**Grade {by}**")