Data input for teal app — cdisc

Function takes datasets and creates CDISCTealData object which can be used in teal applications.

Usage

cdisc_data(..., join_keys, code = "", check = FALSE)

Arguments

...: (TealDataConnector, TealDataset or TealDatasetConnector) elements to include where ADSL data is mandatory.
join_keys: (JoinKeys) or a single (JoinKeySet)
(optional) object with datasets column names used for joining. If empty then it would be automatically derived basing on intersection of datasets primary keys
code: (character) code to reproduce the datasets.
check: (logical) reproducibility check - whether to perform a check that the pre-processing code included in the object definitions actually produces those objects. If check is true and preprocessing code is empty an error will be thrown.

Value

a CDISCTealData object

Details

This function checks if there were keys added to all data sets

Note

This function does not automatically assign keys to TealDataset and TealDatasetConnector objects passed to it. If the keys are needed they should be assigned before calling cdisc_data. See example:

Examples

library(scda)

ADSL <- synthetic_cdisc_data("latest")$adsl
ADTTE <- synthetic_cdisc_data("latest")$adtte

# basic example
cdisc_data(
  cdisc_dataset("ADSL", ADSL),
  cdisc_dataset("ADTTE", ADTTE),
  code = 'ADSL <- synthetic_cdisc_data("latest")$adsl
          ADTTE <- synthetic_cdisc_data("latest")$adtte',
  check = TRUE
)
#> A CDISCTealData object containing 2 TealDataset/TealDatasetConnector object(s) as element(s):
#> --> Element 1:
#> A CDISCTealDataset object containing the following data.frame (400 rows and 44 columns):
#>   STUDYID               USUBJID SUBJID SITEID AGE  AGEU SEX
#> 1 AB12345  AB12345-CHN-3-id-128 id-128  CHN-3  32 YEARS   M
#> 2 AB12345 AB12345-CHN-15-id-262 id-262 CHN-15  35 YEARS   M
#> 3 AB12345  AB12345-RUS-3-id-378 id-378  RUS-3  30 YEARS   F
#> 4 AB12345 AB12345-CHN-11-id-220 id-220 CHN-11  26 YEARS   F
#> 5 AB12345  AB12345-CHN-7-id-267 id-267  CHN-7  40 YEARS   M
#> 6 AB12345 AB12345-CHN-15-id-201 id-201 CHN-15  49 YEARS   M
#>                        RACE                 ETHNIC COUNTRY DTHFL         INVID
#> 1                     ASIAN NOT HISPANIC OR LATINO     CHN     N  INV ID CHN-3
#> 2 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-15
#> 3                     ASIAN NOT HISPANIC OR LATINO     RUS     N  INV ID RUS-3
#> 4                     ASIAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-11
#> 5                     ASIAN                UNKNOWN     CHN     N  INV ID CHN-7
#> 6                     ASIAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-15
#>           INVNAM            ARM ARMCD         ACTARM ACTARMCD         TRT01P
#> 1  Dr. CHN-3 Doe      A: Drug X ARM A      A: Drug X    ARM A      A: Drug X
#> 2 Dr. CHN-15 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#> 3  Dr. RUS-3 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#> 4 Dr. CHN-11 Doe     B: Placebo ARM B     B: Placebo    ARM B     B: Placebo
#> 5  Dr. CHN-7 Doe     B: Placebo ARM B     B: Placebo    ARM B     B: Placebo
#> 6 Dr. CHN-15 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#>           TRT01A REGION1 STRATA1 STRATA2    BMRKR1 BMRKR2 ITTFL SAFFL BMEASIFL
#> 1      A: Drug X    Asia       C      S2 14.424934 MEDIUM     Y     Y        Y
#> 2 C: Combination    Asia       C      S1  4.055463    LOW     Y     Y        N
#> 3 C: Combination Eurasia       A      S1  2.803240   HIGH     Y     Y        Y
#> 4     B: Placebo    Asia       B      S2 10.262734 MEDIUM     Y     Y        Y
#> 5     B: Placebo    Asia       C      S1  6.206763    LOW     Y     Y        N
#> 6 C: Combination    Asia       C      S2  6.906799 MEDIUM     Y     Y        Y
#>   BEP01FL     RANDDT             TRTSDTM             TRTEDTM       EOSSTT
#> 1       Y 2019-02-22 2019-02-24 11:09:18 2021-02-23 22:47:42    COMPLETED
#> 2       N 2019-02-26 2019-02-26 09:05:00 2021-02-25 20:43:24    COMPLETED
#> 3       N 2019-02-24 2019-02-28 03:19:08 2021-02-27 14:57:32    COMPLETED
#> 4       Y 2019-02-27 2019-03-01 13:33:03 2021-03-01 01:11:27    COMPLETED
#> 5       N 2019-03-01 2019-03-02 00:09:16 2021-03-01 11:47:40    COMPLETED
#> 6       N 2019-03-05 2019-03-05 15:23:44 2021-02-17 20:24:57 DISCONTINUED
#>         EOTSTT      EOSDT EOSDY          DCSREAS DTHDT DTHCAUS DTHCAT LDDTHELD
#> 1    COMPLETED 2021-02-23   731             <NA>  <NA>    <NA>   <NA>       NA
#> 2    COMPLETED 2021-02-25   731             <NA>  <NA>    <NA>   <NA>       NA
#> 3    COMPLETED 2021-02-27   731             <NA>  <NA>    <NA>   <NA>       NA
#> 4    COMPLETED 2021-03-01   731             <NA>  <NA>    <NA>   <NA>       NA
#> 5    COMPLETED 2021-03-01   731             <NA>  <NA>    <NA>   <NA>       NA
#> 6 DISCONTINUED 2021-02-17   716 LACK OF EFFICACY  <NA>    <NA>   <NA>       NA
#>   LDDTHGR1   LSTALVDT DTHADY study_duration_secs
#> 1     <NA> 2021-03-05     NA            63113904
#> 2     <NA> 2021-03-15     NA            63113904
#> 3     <NA> 2021-03-15     NA            63113904
#> 4     <NA> 2021-03-17     NA            63113904
#> 5     <NA> 2021-03-25     NA            63113904
#> 6     <NA> 2021-03-01     NA            63113904
#> 
#> ...
#> # A tibble: 6 × 44
#>   STUDYID USUBJID     SUBJID SITEID   AGE AGEU  SEX   RACE  ETHNIC COUNTRY DTHFL
#>   <chr>   <chr>       <chr>  <chr>  <int> <fct> <fct> <fct> <fct>  <fct>   <fct>
#> 1 AB12345 AB12345-CH… id-11  CHN-9     28 YEARS F     NATI… HISPA… CHN     N    
#> 2 AB12345 AB12345-CH… id-352 CHN-16    28 YEARS M     ASIAN HISPA… CHN     N    
#> 3 AB12345 AB12345-CH… id-186 CHN-1     27 YEARS M     ASIAN NOT H… CHN     N    
#> 4 AB12345 AB12345-CH… id-371 CHN-1     28 YEARS F     ASIAN NOT H… CHN     Y    
#> 5 AB12345 AB12345-CH… id-233 CHN-1     36 YEARS F     BLAC… NOT H… CHN     N    
#> 6 AB12345 AB12345-US… id-131 USA-12    44 YEARS F     AMER… NOT H… USA     N    
#> # … with 33 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> #   ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, REGION1 <fct>,
#> #   STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>, BMRKR2 <fct>, ITTFL <fct>,
#> #   SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>, RANDDT <date>, TRTSDTM <dttm>,
#> #   TRTEDTM <dttm>, EOSSTT <fct>, EOTSTT <fct>, EOSDT <date>, EOSDY <int>,
#> #   DCSREAS <fct>, DTHDT <date>, DTHCAUS <fct>, DTHCAT <fct>, LDDTHELD <int>,
#> #   LDDTHGR1 <fct>, LSTALVDT <date>, DTHADY <int>, study_duration_secs <dbl>
#> --> Element 2:
#> A CDISCTealDataset object containing the following data.frame (1600 rows and 55 columns):
#>   STUDYID              USUBJID SUBJID SITEID AGE  AGEU SEX
#> 1 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 2 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 3 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 4 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 5 AB12345 AB12345-BRA-1-id-134 id-134  BRA-1  47 YEARS   M
#> 6 AB12345 AB12345-BRA-1-id-134 id-134  BRA-1  47 YEARS   M
#>                        RACE                 ETHNIC COUNTRY DTHFL        INVID
#> 1 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 2 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 3 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 4 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 5                     WHITE NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 6                     WHITE NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#>          INVNAM       ARM ARMCD    ACTARM ACTARMCD    TRT01P    TRT01A
#> 1 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 2 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 3 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 4 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 5 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 6 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#>         REGION1 STRATA1 STRATA2   BMRKR1 BMRKR2 ITTFL SAFFL BMEASIFL BEP01FL
#> 1 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 2 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 3 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 4 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 5 South America       B      S2 6.462991    LOW     Y     Y        Y       N
#> 6 South America       B      S2 6.462991    LOW     Y     Y        Y       N
#>       RANDDT             TRTSDTM             TRTEDTM       EOSSTT       EOTSTT
#> 1 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 2 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 3 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 4 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 5 2020-11-03 2020-11-04 03:50:33 2022-11-04 15:28:57    COMPLETED    COMPLETED
#> 6 2020-11-03 2020-11-04 03:50:33 2022-11-04 15:28:57    COMPLETED    COMPLETED
#>        EOSDT EOSDY       DCSREAS DTHDT DTHCAUS DTHCAT LDDTHELD LDDTHGR1
#> 1 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 2 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 3 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 4 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 5 2022-11-04   731          <NA>  <NA>    <NA>   <NA>       NA     <NA>
#> 6 2022-11-04   731          <NA>  <NA>    <NA>   <NA>       NA     <NA>
#>     LSTALVDT DTHADY study_duration_secs ASEQ TTESEQ
#> 1 2021-03-07     NA            63113904    2      2
#> 2 2021-03-07     NA            63113904    4      4
#> 3 2021-03-07     NA            63113904    3      3
#> 4 2021-03-07     NA            63113904    1      1
#> 5 2022-11-15     NA            63113904    4      4
#> 6 2022-11-15     NA            63113904    2      2
#>                            PARAM PARAMCD      AVAL AVALU       ADTM ADY CNSR
#> 1 Duration of Confirmed Response    CRSD 1273.8498  DAYS 2020-08-13 158    1
#> 2            Event Free Survival     EFS  135.9787  DAYS 2021-02-16 345    0
#> 3               Overall Survival      OS 1759.8678  DAYS 2020-11-05 242    0
#> 4      Progression Free Survival     PFS  241.1912  DAYS 2020-07-23 137    0
#> 5 Duration of Confirmed Response    CRSD  544.5728  DAYS 2021-10-25 355    0
#> 6            Event Free Survival     EFS  401.2725  DAYS 2021-05-05 182    1
#>                      EVNTDESC                      CNSDTDSC
#> 1 Last Date Known To Be Alive    End of AE Reporting Period
#> 2                       Death                              
#> 3                       Death                              
#> 4         Disease Progression                              
#> 5                       Death                              
#> 6 Last Date Known To Be Alive Completion or Discontinuation
#> 
#> ...
#> # A tibble: 6 × 55
#>   STUDYID USUBJID     SUBJID SITEID   AGE AGEU  SEX   RACE  ETHNIC COUNTRY DTHFL
#>   <chr>   <chr>       <chr>  <chr>  <int> <fct> <fct> <fct> <fct>  <fct>   <fct>
#> 1 AB12345 AB12345-US… id-206 USA-8     34 YEARS F     ASIAN NOT H… USA     N    
#> 2 AB12345 AB12345-US… id-206 USA-8     34 YEARS F     ASIAN NOT H… USA     N    
#> 3 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 4 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 5 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 6 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> # … with 44 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> #   ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, REGION1 <fct>,
#> #   STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>, BMRKR2 <fct>, ITTFL <fct>,
#> #   SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>, RANDDT <date>, TRTSDTM <dttm>,
#> #   TRTEDTM <dttm>, EOSSTT <fct>, EOTSTT <fct>, EOSDT <date>, EOSDY <int>,
#> #   DCSREAS <fct>, DTHDT <date>, DTHCAUS <fct>, DTHCAT <fct>, LDDTHELD <int>,
#> #   LDDTHGR1 <fct>, LSTALVDT <date>, DTHADY <int>, study_duration_secs <dbl>, …

# Example with keys
cdisc_data(
  cdisc_dataset("ADSL", ADSL,
    keys = c("STUDYID", "USUBJID")
  ),
  cdisc_dataset("ADTTE", ADTTE,
    keys = c("STUDYID", "USUBJID", "PARAMCD"),
    parent = "ADSL"
  ),
  join_keys = join_keys(
    join_key(
      "ADSL",
      "ADTTE",
      c("STUDYID" = "STUDYID", "USUBJID" = "USUBJID")
    )
  ),
  code = 'ADSL <- synthetic_cdisc_data("latest")$adsl
          ADTTE <- synthetic_cdisc_data("latest")$adtte',
  check = TRUE
)
#> A CDISCTealData object containing 2 TealDataset/TealDatasetConnector object(s) as element(s):
#> --> Element 1:
#> A CDISCTealDataset object containing the following data.frame (400 rows and 44 columns):
#>   STUDYID               USUBJID SUBJID SITEID AGE  AGEU SEX
#> 1 AB12345  AB12345-CHN-3-id-128 id-128  CHN-3  32 YEARS   M
#> 2 AB12345 AB12345-CHN-15-id-262 id-262 CHN-15  35 YEARS   M
#> 3 AB12345  AB12345-RUS-3-id-378 id-378  RUS-3  30 YEARS   F
#> 4 AB12345 AB12345-CHN-11-id-220 id-220 CHN-11  26 YEARS   F
#> 5 AB12345  AB12345-CHN-7-id-267 id-267  CHN-7  40 YEARS   M
#> 6 AB12345 AB12345-CHN-15-id-201 id-201 CHN-15  49 YEARS   M
#>                        RACE                 ETHNIC COUNTRY DTHFL         INVID
#> 1                     ASIAN NOT HISPANIC OR LATINO     CHN     N  INV ID CHN-3
#> 2 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-15
#> 3                     ASIAN NOT HISPANIC OR LATINO     RUS     N  INV ID RUS-3
#> 4                     ASIAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-11
#> 5                     ASIAN                UNKNOWN     CHN     N  INV ID CHN-7
#> 6                     ASIAN NOT HISPANIC OR LATINO     CHN     N INV ID CHN-15
#>           INVNAM            ARM ARMCD         ACTARM ACTARMCD         TRT01P
#> 1  Dr. CHN-3 Doe      A: Drug X ARM A      A: Drug X    ARM A      A: Drug X
#> 2 Dr. CHN-15 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#> 3  Dr. RUS-3 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#> 4 Dr. CHN-11 Doe     B: Placebo ARM B     B: Placebo    ARM B     B: Placebo
#> 5  Dr. CHN-7 Doe     B: Placebo ARM B     B: Placebo    ARM B     B: Placebo
#> 6 Dr. CHN-15 Doe C: Combination ARM C C: Combination    ARM C C: Combination
#>           TRT01A REGION1 STRATA1 STRATA2    BMRKR1 BMRKR2 ITTFL SAFFL BMEASIFL
#> 1      A: Drug X    Asia       C      S2 14.424934 MEDIUM     Y     Y        Y
#> 2 C: Combination    Asia       C      S1  4.055463    LOW     Y     Y        N
#> 3 C: Combination Eurasia       A      S1  2.803240   HIGH     Y     Y        Y
#> 4     B: Placebo    Asia       B      S2 10.262734 MEDIUM     Y     Y        Y
#> 5     B: Placebo    Asia       C      S1  6.206763    LOW     Y     Y        N
#> 6 C: Combination    Asia       C      S2  6.906799 MEDIUM     Y     Y        Y
#>   BEP01FL     RANDDT             TRTSDTM             TRTEDTM       EOSSTT
#> 1       Y 2019-02-22 2019-02-24 11:09:18 2021-02-23 22:47:42    COMPLETED
#> 2       N 2019-02-26 2019-02-26 09:05:00 2021-02-25 20:43:24    COMPLETED
#> 3       N 2019-02-24 2019-02-28 03:19:08 2021-02-27 14:57:32    COMPLETED
#> 4       Y 2019-02-27 2019-03-01 13:33:03 2021-03-01 01:11:27    COMPLETED
#> 5       N 2019-03-01 2019-03-02 00:09:16 2021-03-01 11:47:40    COMPLETED
#> 6       N 2019-03-05 2019-03-05 15:23:44 2021-02-17 20:24:57 DISCONTINUED
#>         EOTSTT      EOSDT EOSDY          DCSREAS DTHDT DTHCAUS DTHCAT LDDTHELD
#> 1    COMPLETED 2021-02-23   731             <NA>  <NA>    <NA>   <NA>       NA
#> 2    COMPLETED 2021-02-25   731             <NA>  <NA>    <NA>   <NA>       NA
#> 3    COMPLETED 2021-02-27   731             <NA>  <NA>    <NA>   <NA>       NA
#> 4    COMPLETED 2021-03-01   731             <NA>  <NA>    <NA>   <NA>       NA
#> 5    COMPLETED 2021-03-01   731             <NA>  <NA>    <NA>   <NA>       NA
#> 6 DISCONTINUED 2021-02-17   716 LACK OF EFFICACY  <NA>    <NA>   <NA>       NA
#>   LDDTHGR1   LSTALVDT DTHADY study_duration_secs
#> 1     <NA> 2021-03-05     NA            63113904
#> 2     <NA> 2021-03-15     NA            63113904
#> 3     <NA> 2021-03-15     NA            63113904
#> 4     <NA> 2021-03-17     NA            63113904
#> 5     <NA> 2021-03-25     NA            63113904
#> 6     <NA> 2021-03-01     NA            63113904
#> 
#> ...
#> # A tibble: 6 × 44
#>   STUDYID USUBJID     SUBJID SITEID   AGE AGEU  SEX   RACE  ETHNIC COUNTRY DTHFL
#>   <chr>   <chr>       <chr>  <chr>  <int> <fct> <fct> <fct> <fct>  <fct>   <fct>
#> 1 AB12345 AB12345-CH… id-11  CHN-9     28 YEARS F     NATI… HISPA… CHN     N    
#> 2 AB12345 AB12345-CH… id-352 CHN-16    28 YEARS M     ASIAN HISPA… CHN     N    
#> 3 AB12345 AB12345-CH… id-186 CHN-1     27 YEARS M     ASIAN NOT H… CHN     N    
#> 4 AB12345 AB12345-CH… id-371 CHN-1     28 YEARS F     ASIAN NOT H… CHN     Y    
#> 5 AB12345 AB12345-CH… id-233 CHN-1     36 YEARS F     BLAC… NOT H… CHN     N    
#> 6 AB12345 AB12345-US… id-131 USA-12    44 YEARS F     AMER… NOT H… USA     N    
#> # … with 33 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> #   ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, REGION1 <fct>,
#> #   STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>, BMRKR2 <fct>, ITTFL <fct>,
#> #   SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>, RANDDT <date>, TRTSDTM <dttm>,
#> #   TRTEDTM <dttm>, EOSSTT <fct>, EOTSTT <fct>, EOSDT <date>, EOSDY <int>,
#> #   DCSREAS <fct>, DTHDT <date>, DTHCAUS <fct>, DTHCAT <fct>, LDDTHELD <int>,
#> #   LDDTHGR1 <fct>, LSTALVDT <date>, DTHADY <int>, study_duration_secs <dbl>
#> --> Element 2:
#> A CDISCTealDataset object containing the following data.frame (1600 rows and 55 columns):
#>   STUDYID              USUBJID SUBJID SITEID AGE  AGEU SEX
#> 1 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 2 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 3 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 4 AB12345 AB12345-BRA-1-id-105 id-105  BRA-1  38 YEARS   M
#> 5 AB12345 AB12345-BRA-1-id-134 id-134  BRA-1  47 YEARS   M
#> 6 AB12345 AB12345-BRA-1-id-134 id-134  BRA-1  47 YEARS   M
#>                        RACE                 ETHNIC COUNTRY DTHFL        INVID
#> 1 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 2 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 3 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 4 BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 5                     WHITE NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#> 6                     WHITE NOT HISPANIC OR LATINO     BRA     N INV ID BRA-1
#>          INVNAM       ARM ARMCD    ACTARM ACTARMCD    TRT01P    TRT01A
#> 1 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 2 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 3 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 4 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 5 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#> 6 Dr. BRA-1 Doe A: Drug X ARM A A: Drug X    ARM A A: Drug X A: Drug X
#>         REGION1 STRATA1 STRATA2   BMRKR1 BMRKR2 ITTFL SAFFL BMEASIFL BEP01FL
#> 1 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 2 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 3 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 4 South America       B      S1 4.156914 MEDIUM     Y     Y        Y       Y
#> 5 South America       B      S2 6.462991    LOW     Y     Y        Y       N
#> 6 South America       B      S2 6.462991    LOW     Y     Y        Y       N
#>       RANDDT             TRTSDTM             TRTEDTM       EOSSTT       EOTSTT
#> 1 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 2 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 3 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 4 2020-03-08 2020-03-08 05:28:11 2021-02-17 18:49:59 DISCONTINUED DISCONTINUED
#> 5 2020-11-03 2020-11-04 03:50:33 2022-11-04 15:28:57    COMPLETED    COMPLETED
#> 6 2020-11-03 2020-11-04 03:50:33 2022-11-04 15:28:57    COMPLETED    COMPLETED
#>        EOSDT EOSDY       DCSREAS DTHDT DTHCAUS DTHCAT LDDTHELD LDDTHGR1
#> 1 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 2 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 3 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 4 2021-02-17   347 ADVERSE EVENT  <NA>    <NA>   <NA>       NA     <NA>
#> 5 2022-11-04   731          <NA>  <NA>    <NA>   <NA>       NA     <NA>
#> 6 2022-11-04   731          <NA>  <NA>    <NA>   <NA>       NA     <NA>
#>     LSTALVDT DTHADY study_duration_secs ASEQ TTESEQ
#> 1 2021-03-07     NA            63113904    2      2
#> 2 2021-03-07     NA            63113904    4      4
#> 3 2021-03-07     NA            63113904    3      3
#> 4 2021-03-07     NA            63113904    1      1
#> 5 2022-11-15     NA            63113904    4      4
#> 6 2022-11-15     NA            63113904    2      2
#>                            PARAM PARAMCD      AVAL AVALU       ADTM ADY CNSR
#> 1 Duration of Confirmed Response    CRSD 1273.8498  DAYS 2020-08-13 158    1
#> 2            Event Free Survival     EFS  135.9787  DAYS 2021-02-16 345    0
#> 3               Overall Survival      OS 1759.8678  DAYS 2020-11-05 242    0
#> 4      Progression Free Survival     PFS  241.1912  DAYS 2020-07-23 137    0
#> 5 Duration of Confirmed Response    CRSD  544.5728  DAYS 2021-10-25 355    0
#> 6            Event Free Survival     EFS  401.2725  DAYS 2021-05-05 182    1
#>                      EVNTDESC                      CNSDTDSC
#> 1 Last Date Known To Be Alive    End of AE Reporting Period
#> 2                       Death                              
#> 3                       Death                              
#> 4         Disease Progression                              
#> 5                       Death                              
#> 6 Last Date Known To Be Alive Completion or Discontinuation
#> 
#> ...
#> # A tibble: 6 × 55
#>   STUDYID USUBJID     SUBJID SITEID   AGE AGEU  SEX   RACE  ETHNIC COUNTRY DTHFL
#>   <chr>   <chr>       <chr>  <chr>  <int> <fct> <fct> <fct> <fct>  <fct>   <fct>
#> 1 AB12345 AB12345-US… id-206 USA-8     34 YEARS F     ASIAN NOT H… USA     N    
#> 2 AB12345 AB12345-US… id-206 USA-8     34 YEARS F     ASIAN NOT H… USA     N    
#> 3 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 4 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 5 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> 6 AB12345 AB12345-US… id-130 USA-9     40 YEARS M     ASIAN NOT H… USA     N    
#> # … with 44 more variables: INVID <chr>, INVNAM <chr>, ARM <fct>, ARMCD <fct>,
#> #   ACTARM <fct>, ACTARMCD <fct>, TRT01P <fct>, TRT01A <fct>, REGION1 <fct>,
#> #   STRATA1 <fct>, STRATA2 <fct>, BMRKR1 <dbl>, BMRKR2 <fct>, ITTFL <fct>,
#> #   SAFFL <fct>, BMEASIFL <fct>, BEP01FL <fct>, RANDDT <date>, TRTSDTM <dttm>,
#> #   TRTEDTM <dttm>, EOSSTT <fct>, EOTSTT <fct>, EOSDT <date>, EOSDY <int>,
#> #   DCSREAS <fct>, DTHDT <date>, DTHCAUS <fct>, DTHCAT <fct>, LDDTHELD <int>,
#> #   LDDTHGR1 <fct>, LSTALVDT <date>, DTHADY <int>, study_duration_secs <dbl>, …