Adverse Events of Special Interest (AESI) example dataset
aesi.Rdaesi is a modified version of the random.cdisc.data::cadae dataset,
filtered to include only analysis-flagged records (ANL01FL == "Y") and
extended with binary indicator variables corresponding to adverse events of
special interest (AESIs).
Format
A data.frame with a subset of rows from cadae and additional
derived columns including:
- FATAL
Logical flag for fatal AEs (
AESDTH == "Y").- SEV
Logical flag for severe AEs (
AESEV == "SEVERE").- SER
Logical flag for serious AEs (
AESER == "Y").- SERWD
Serious AE leading to withdrawal (
AESER == "Y" & AEACN == "DRUG WITHDRAWN").- SERDSM
Serious AE leading to dose modification/interruption.
- RELSER
Serious and related AE.
- WD
AE leading to withdrawal.
- DSM
AE leading to dose modification/interruption.
- REL
Related AE.
- RELWD
Related AE leading to withdrawal.
- RELDSM
Related AE leading to dose modification/interruption.
Details
These derived flags include seriousness, severity, fatality, relatedness, and treatment consequence (e.g., dose modification or withdrawal), and are used to illustrate key safety summaries in clinical reporting.
Each derived variable is labeled using with_label() for compatibility
with tabulation functions.
This dataset is included in {dtlg} to support function testing, usage
examples, and reproducible safety analyses.
Examples
aesi
#> STUDYID USUBJID SUBJID SITEID AGE AGEU SEX RACE
#> <char> <char> <char> <char> <int> <fctr> <fctr> <fctr>
#> 1: AB12345 AB12345-BRA-1-id-134 id-134 BRA-1 47 YEARS M WHITE
#> 2: AB12345 AB12345-BRA-1-id-134 id-134 BRA-1 47 YEARS M WHITE
#> 3: AB12345 AB12345-BRA-1-id-134 id-134 BRA-1 47 YEARS M WHITE
#> 4: AB12345 AB12345-BRA-1-id-134 id-134 BRA-1 47 YEARS M WHITE
#> 5: AB12345 AB12345-BRA-1-id-141 id-141 BRA-1 35 YEARS F WHITE
#> ---
#> 1582: AB12345 AB12345-USA-8-id-206 id-206 USA-8 34 YEARS F ASIAN
#> 1583: AB12345 AB12345-USA-8-id-206 id-206 USA-8 34 YEARS F ASIAN
#> 1584: AB12345 AB12345-USA-9-id-130 id-130 USA-9 40 YEARS M ASIAN
#> 1585: AB12345 AB12345-USA-9-id-130 id-130 USA-9 40 YEARS M ASIAN
#> 1586: AB12345 AB12345-USA-9-id-130 id-130 USA-9 40 YEARS M ASIAN
#> ETHNIC COUNTRY DTHFL INVID INVNAM
#> <fctr> <fctr> <fctr> <char> <char>
#> 1: NOT HISPANIC OR LATINO BRA Y INV ID BRA-1 Dr. BRA-1 Doe
#> 2: NOT HISPANIC OR LATINO BRA Y INV ID BRA-1 Dr. BRA-1 Doe
#> 3: NOT HISPANIC OR LATINO BRA Y INV ID BRA-1 Dr. BRA-1 Doe
#> 4: NOT HISPANIC OR LATINO BRA Y INV ID BRA-1 Dr. BRA-1 Doe
#> 5: NOT HISPANIC OR LATINO BRA N INV ID BRA-1 Dr. BRA-1 Doe
#> ---
#> 1582: NOT HISPANIC OR LATINO USA N INV ID USA-8 Dr. USA-8 Doe
#> 1583: NOT HISPANIC OR LATINO USA N INV ID USA-8 Dr. USA-8 Doe
#> 1584: NOT HISPANIC OR LATINO USA N INV ID USA-9 Dr. USA-9 Doe
#> 1585: NOT HISPANIC OR LATINO USA N INV ID USA-9 Dr. USA-9 Doe
#> 1586: NOT HISPANIC OR LATINO USA N INV ID USA-9 Dr. USA-9 Doe
#> ARM ARMCD ACTARM ACTARMCD TRT01P
#> <fctr> <fctr> <fctr> <fctr> <fctr>
#> 1: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 2: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 3: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 4: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 5: C: Combination ARM C C: Combination ARM C C: Combination
#> ---
#> 1582: C: Combination ARM C C: Combination ARM C C: Combination
#> 1583: C: Combination ARM C C: Combination ARM C C: Combination
#> 1584: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 1585: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> 1586: A: Drug X ARM A A: Drug X ARM A A: Drug X
#> TRT01A TRT02P TRT02A REGION1 STRATA1
#> <fctr> <fctr> <fctr> <fctr> <fctr>
#> 1: A: Drug X B: Placebo A: Drug X South America B
#> 2: A: Drug X B: Placebo A: Drug X South America B
#> 3: A: Drug X B: Placebo A: Drug X South America B
#> 4: A: Drug X B: Placebo A: Drug X South America B
#> 5: C: Combination C: Combination C: Combination South America B
#> ---
#> 1582: C: Combination B: Placebo C: Combination North America B
#> 1583: C: Combination B: Placebo C: Combination North America B
#> 1584: A: Drug X C: Combination C: Combination North America A
#> 1585: A: Drug X C: Combination C: Combination North America A
#> 1586: A: Drug X C: Combination C: Combination North America A
#> STRATA2 BMRKR1 BMRKR2 ITTFL SAFFL BMEASIFL BEP01FL AEWITHFL
#> <fctr> <num> <fctr> <fctr> <fctr> <fctr> <fctr> <fctr>
#> 1: S2 6.462991 LOW Y Y Y N N
#> 2: S2 6.462991 LOW Y Y Y N N
#> 3: S2 6.462991 LOW Y Y Y N N
#> 4: S2 6.462991 LOW Y Y Y N N
#> 5: S1 7.516076 HIGH Y Y Y Y N
#> ---
#> 1582: S1 14.478057 HIGH Y Y Y Y N
#> 1583: S1 14.478057 HIGH Y Y Y Y N
#> 1584: S1 1.280525 MEDIUM Y Y N N N
#> 1585: S1 1.280525 MEDIUM Y Y N N N
#> 1586: S1 1.280525 MEDIUM Y Y N N N
#> RANDDT TRTSDTM TRTEDTM TRT01SDTM
#> <Date> <POSc> <POSc> <POSc>
#> 1: 2020-11-03 2020-11-04 04:08:58 2022-02-20 03:33:55 2020-11-04 04:08:58
#> 2: 2020-11-03 2020-11-04 04:08:58 2022-02-20 03:33:55 2020-11-04 04:08:58
#> 3: 2020-11-03 2020-11-04 04:08:58 2022-02-20 03:33:55 2020-11-04 04:08:58
#> 4: 2020-11-03 2020-11-04 04:08:58 2022-02-20 03:33:55 2020-11-04 04:08:58
#> 5: 2020-07-22 2020-07-25 14:26:21 2023-07-26 08:26:21 2020-07-25 14:26:21
#> ---
#> 1582: 2019-07-19 2019-07-22 10:23:30 2022-07-22 04:23:30 2019-07-22 10:23:30
#> 1583: 2019-07-19 2019-07-22 10:23:30 2022-07-22 04:23:30 2019-07-22 10:23:30
#> 1584: 2020-07-17 2020-07-18 19:43:32 2023-07-19 13:43:32 2020-07-18 19:43:32
#> 1585: 2020-07-17 2020-07-18 19:43:32 2023-07-19 13:43:32 2020-07-18 19:43:32
#> 1586: 2020-07-17 2020-07-18 19:43:32 2023-07-19 13:43:32 2020-07-18 19:43:32
#> TRT01EDTM TRT02SDTM TRT02EDTM
#> <POSc> <POSc> <POSc>
#> 1: 2021-02-19 21:33:55 2021-02-19 21:33:55 2022-02-20 03:33:55
#> 2: 2021-02-19 21:33:55 2021-02-19 21:33:55 2022-02-20 03:33:55
#> 3: 2021-02-19 21:33:55 2021-02-19 21:33:55 2022-02-20 03:33:55
#> 4: 2021-02-19 21:33:55 2021-02-19 21:33:55 2022-02-20 03:33:55
#> 5: 2022-07-26 02:26:21 2022-07-26 02:26:21 2023-07-26 08:26:21
#> ---
#> 1582: 2021-07-21 22:23:30 2021-07-21 22:23:30 2022-07-22 04:23:30
#> 1583: 2021-07-21 22:23:30 2021-07-21 22:23:30 2022-07-22 04:23:30
#> 1584: 2022-07-19 07:43:32 2022-07-19 07:43:32 2023-07-19 13:43:32
#> 1585: 2022-07-19 07:43:32 2022-07-19 07:43:32 2023-07-19 13:43:32
#> 1586: 2022-07-19 07:43:32 2022-07-19 07:43:32 2023-07-19 13:43:32
#> AP01SDTM AP01EDTM AP02SDTM
#> <POSc> <POSc> <POSc>
#> 1: 2020-11-04 04:08:58 2021-02-19 21:33:55 2021-02-19 21:33:55
#> 2: 2020-11-04 04:08:58 2021-02-19 21:33:55 2021-02-19 21:33:55
#> 3: 2020-11-04 04:08:58 2021-02-19 21:33:55 2021-02-19 21:33:55
#> 4: 2020-11-04 04:08:58 2021-02-19 21:33:55 2021-02-19 21:33:55
#> 5: 2020-07-25 14:26:21 2022-07-26 02:26:21 2022-07-26 02:26:21
#> ---
#> 1582: 2019-07-22 10:23:30 2021-07-21 22:23:30 2021-07-21 22:23:30
#> 1583: 2019-07-22 10:23:30 2021-07-21 22:23:30 2021-07-21 22:23:30
#> 1584: 2020-07-18 19:43:32 2022-07-19 07:43:32 2022-07-19 07:43:32
#> 1585: 2020-07-18 19:43:32 2022-07-19 07:43:32 2022-07-19 07:43:32
#> 1586: 2020-07-18 19:43:32 2022-07-19 07:43:32 2022-07-19 07:43:32
#> AP02EDTM EOSSTT EOTSTT EOSDT EOSDY DCSREAS
#> <POSc> <fctr> <fctr> <Date> <int> <fctr>
#> 1: 2022-02-20 03:33:55 DISCONTINUED DISCONTINUED 2022-02-20 473 DEATH
#> 2: 2022-02-20 03:33:55 DISCONTINUED DISCONTINUED 2022-02-20 473 DEATH
#> 3: 2022-02-20 03:33:55 DISCONTINUED DISCONTINUED 2022-02-20 473 DEATH
#> 4: 2022-02-20 03:33:55 DISCONTINUED DISCONTINUED 2022-02-20 473 DEATH
#> 5: 2023-07-26 08:26:21 COMPLETED COMPLETED 2023-07-26 1096 <NA>
#> ---
#> 1582: 2022-07-22 04:23:30 COMPLETED COMPLETED 2022-07-22 1096 <NA>
#> 1583: 2022-07-22 04:23:30 COMPLETED COMPLETED 2022-07-22 1096 <NA>
#> 1584: 2023-07-19 13:43:32 COMPLETED COMPLETED 2023-07-19 1096 <NA>
#> 1585: 2023-07-19 13:43:32 COMPLETED COMPLETED 2023-07-19 1096 <NA>
#> 1586: 2023-07-19 13:43:32 COMPLETED COMPLETED 2023-07-19 1096 <NA>
#> DTHDT DTHCAUS DTHCAT LDDTHELD LDDTHGR1 LSTALVDT
#> <Date> <fctr> <fctr> <int> <fctr> <Date>
#> 1: 2022-03-16 ADVERSE EVENT ADVERSE EVENT 24 <=30 2022-03-16
#> 2: 2022-03-16 ADVERSE EVENT ADVERSE EVENT 24 <=30 2022-03-16
#> 3: 2022-03-16 ADVERSE EVENT ADVERSE EVENT 24 <=30 2022-03-16
#> 4: 2022-03-16 ADVERSE EVENT ADVERSE EVENT 24 <=30 2022-03-16
#> 5: <NA> <NA> <NA> NA <NA> 2023-08-08
#> ---
#> 1582: <NA> <NA> <NA> NA <NA> 2022-08-07
#> 1583: <NA> <NA> <NA> NA <NA> 2022-08-07
#> 1584: <NA> <NA> <NA> NA <NA> 2023-08-09
#> 1585: <NA> <NA> <NA> NA <NA> 2023-08-09
#> 1586: <NA> <NA> <NA> NA <NA> 2023-08-09
#> DTHADY ADTHAUT ASEQ AESEQ AETERM AELLT AEDECOD
#> <int> <fctr> <int> <int> <fctr> <fctr> <char>
#> 1: 496 Yes 1 1 trm B.2.1.2.1 llt B.2.1.2.1 dcd B.2.1.2.1
#> 2: 496 Yes 2 2 trm D.1.1.4.2 llt D.1.1.4.2 dcd D.1.1.4.2
#> 3: 496 Yes 3 3 trm A.1.1.1.2 llt A.1.1.1.2 dcd A.1.1.1.2
#> 4: 496 Yes 4 4 trm A.1.1.1.2 llt A.1.1.1.2 dcd A.1.1.1.2
#> 5: NA <NA> 1 1 trm B.2.1.2.1 llt B.2.1.2.1 dcd B.2.1.2.1
#> ---
#> 1582: NA <NA> 7 7 trm B.2.2.3.1 llt B.2.2.3.1 dcd B.2.2.3.1
#> 1583: NA <NA> 8 8 trm C.2.1.2.1 llt C.2.1.2.1 dcd C.2.1.2.1
#> 1584: NA <NA> 1 1 trm D.1.1.1.1 llt D.1.1.1.1 dcd D.1.1.1.1
#> 1585: NA <NA> 2 2 trm D.1.1.4.2 llt D.1.1.4.2 dcd D.1.1.4.2
#> 1586: NA <NA> 3 3 trm D.1.1.4.2 llt D.1.1.4.2 dcd D.1.1.4.2
#> AEHLT AEHLGT AEBODSYS AESOC AESEV AESER AEACN
#> <fctr> <fctr> <fctr> <fctr> <fctr> <fctr> <char>
#> 1: hlt B.2.1.2 hlgt B.2.1 cl B.2 cl B MODERATE N DOSE NOT CHANGED
#> 2: hlt D.1.1.4 hlgt D.1.1 cl D.1 cl D MODERATE N DOSE NOT CHANGED
#> 3: hlt A.1.1.1 hlgt A.1.1 cl A.1 cl A MODERATE Y DOSE NOT CHANGED
#> 4: hlt A.1.1.1 hlgt A.1.1 cl A.1 cl A MODERATE Y DOSE NOT CHANGED
#> 5: hlt B.2.1.2 hlgt B.2.1 cl B.2 cl B MODERATE N DRUG WITHDRAWN
#> ---
#> 1582: hlt B.2.2.3 hlgt B.2.2 cl B.2 cl B MILD Y DOSE NOT CHANGED
#> 1583: hlt C.2.1.2 hlgt C.2.1 cl C.2 cl C MODERATE N DOSE NOT CHANGED
#> 1584: hlt D.1.1.1 hlgt D.1.1 cl D.1 cl D SEVERE Y DOSE NOT CHANGED
#> 1585: hlt D.1.1.4 hlgt D.1.1 cl D.1 cl D MODERATE N DOSE NOT CHANGED
#> 1586: hlt D.1.1.4 hlgt D.1.1 cl D.1 cl D MODERATE N DRUG INTERRUPTED
#> AEREL AEOUT AESDTH AESCONG AESDISAB AESHOSP AESLIFE
#> <fctr> <char> <char> <fctr> <fctr> <fctr> <fctr>
#> 1: N RECOVERING/RESOLVING N N Y N N
#> 2: N RECOVERING/RESOLVING N N Y N N
#> 3: N RECOVERING/RESOLVING N N Y N N
#> 4: N RECOVERING/RESOLVING Y Y N N N
#> 5: N RECOVERED/RESOLVED N N N Y N
#> ---
#> 1582: N RECOVERED/RESOLVED N N N Y N
#> 1583: Y RECOVERING/RESOLVING N N N N N
#> 1584: Y FATAL N N N N N
#> 1585: N RECOVERING/RESOLVING N N N N N
#> 1586: N RECOVERING/RESOLVING N N N Y N
#> AESMIE TRTEMFL AECONTRT ASTDTM AENDTM ASTDY
#> <fctr> <fctr> <fctr> <POSc> <POSc> <int>
#> 1: N Y Y 2021-04-15 04:08:58 2021-10-04 04:08:58 162
#> 2: N Y N 2021-05-19 04:08:58 2021-10-31 04:08:58 196
#> 3: N Y Y 2021-09-21 04:08:58 2022-02-16 04:08:58 321
#> 4: N Y N 2021-12-02 04:08:58 2022-01-13 04:08:58 393
#> 5: N Y Y 2021-08-16 14:26:21 2021-08-26 14:26:21 387
#> ---
#> 1582: N Y N 2021-04-22 10:23:30 2022-03-17 10:23:30 640
#> 1583: Y Y N 2021-05-18 10:23:30 2022-01-15 10:23:30 666
#> 1584: N Y Y 2020-08-29 19:43:32 2021-10-15 19:43:32 42
#> 1585: Y Y N 2022-09-30 19:43:32 2022-11-26 19:43:32 804
#> 1586: N Y N 2023-04-24 19:43:32 2023-04-25 19:43:32 1010
#> AENDY LDOSEDTM LDRELTM AETOXGR SMQ01NAM
#> <int> <POSc> <num> <fctr> <char>
#> 1: 334 2020-11-07 09:05:04 228663.896 3 <NA>
#> 2: 361 2021-05-17 07:21:09 2687.814 3 <NA>
#> 3: 469 2021-05-23 15:14:37 173574.345 2 <NA>
#> 4: 435 2021-03-19 08:52:05 371236.878 2 <NA>
#> 5: 397 2021-07-22 06:04:04 36502.291 3 <NA>
#> ---
#> 1582: 969 2020-08-07 02:09:27 372014.055 1 C.1.1.1.3/B.2.2.3.1 AESI
#> 1583: 908 2019-08-29 14:42:51 904060.651 2 <NA>
#> 1584: 454 2020-08-27 10:57:40 3405.874 5 <NA>
#> 1585: 861 2021-01-10 19:19:14 904344.302 3 <NA>
#> 1586: 1011 2022-11-05 12:59:20 245204.199 3 <NA>
#> SMQ02NAM SMQ01SC SMQ02SC CQ01NAM ANL01FL AERELNST
#> <char> <char> <char> <char> <fctr> <fctr>
#> 1: <NA> <NA> <NA> <NA> Y NONE
#> 2: <NA> <NA> <NA> <NA> Y CONCURRENT ILLNESS
#> 3: <NA> <NA> <NA> <NA> Y CONCURRENT ILLNESS
#> 4: <NA> <NA> <NA> <NA> Y CONCURRENT ILLNESS
#> 5: <NA> <NA> <NA> <NA> Y CONCURRENT ILLNESS
#> ---
#> 1582: <NA> BROAD <NA> <NA> Y OTHER
#> 1583: <NA> <NA> <NA> <NA> Y OTHER
#> 1584: <NA> <NA> <NA> <NA> Y DISEASE UNDER STUDY
#> 1585: <NA> <NA> <NA> <NA> Y OTHER
#> 1586: <NA> <NA> <NA> <NA> Y OTHER
#> AEACNOTH FATAL SEV SER SERWD SERDSM RELSER
#> <fctr> <lgcl> <lgcl> <lgcl> <lgcl> <lgcl> <lgcl>
#> 1: PROCEDURE/SURGERY FALSE FALSE FALSE FALSE FALSE FALSE
#> 2: MEDICATION FALSE FALSE FALSE FALSE FALSE FALSE
#> 3: SUBJECT DISCONTINUED FROM STUDY FALSE FALSE TRUE FALSE FALSE FALSE
#> 4: SUBJECT DISCONTINUED FROM STUDY TRUE FALSE TRUE FALSE FALSE FALSE
#> 5: PROCEDURE/SURGERY FALSE FALSE FALSE FALSE FALSE FALSE
#> ---
#> 1582: PROCEDURE/SURGERY FALSE FALSE TRUE FALSE FALSE FALSE
#> 1583: NONE FALSE FALSE FALSE FALSE FALSE FALSE
#> 1584: SUBJECT DISCONTINUED FROM STUDY FALSE TRUE TRUE FALSE FALSE TRUE
#> 1585: SUBJECT DISCONTINUED FROM STUDY FALSE FALSE FALSE FALSE FALSE FALSE
#> 1586: PROCEDURE/SURGERY FALSE FALSE FALSE FALSE FALSE FALSE
#> WD DSM REL RELWD RELDSM
#> <lgcl> <lgcl> <lgcl> <lgcl> <lgcl>
#> 1: FALSE FALSE FALSE FALSE FALSE
#> 2: FALSE FALSE FALSE FALSE FALSE
#> 3: FALSE FALSE FALSE FALSE FALSE
#> 4: FALSE FALSE FALSE FALSE FALSE
#> 5: TRUE FALSE FALSE FALSE FALSE
#> ---
#> 1582: FALSE FALSE FALSE FALSE FALSE
#> 1583: FALSE FALSE TRUE FALSE FALSE
#> 1584: FALSE FALSE TRUE FALSE FALSE
#> 1585: FALSE FALSE FALSE FALSE FALSE
#> 1586: FALSE TRUE FALSE FALSE FALSE