TL Catalog
  1. Listings
  2. Exposure
  3. LSIEX01
  • Introduction

  • Index

  • Tables
    • Adverse Events
      • TSFAE01A
      • TSFAE01B
      • TSFAE02
      • TSFAE02A
      • TSFAE03
      • TSFAE03A
      • TSFAE04
      • TSFAE04A
      • TSFAE05
      • TSFAE05A
      • TSFAE06A
      • TSFAE06B
      • TSFAE07A
      • TSFAE07B
      • TSFAE08
      • TSFAE09
      • TSFAE10
      • TSFAE11
      • TSFAE12
      • TSFAE13
      • TSFAE14
      • TSFAE15
      • TSFAE16
      • TSFAE17A
      • TSFAE17B
      • TSFAE17C
      • TSFAE17D
      • TSFAE19A
      • TSFAE19B
      • TSFAE19C
      • TSFAE19D
      • TSFAE20A
      • TSFAE20B
      • TSFAE20C
      • TSFAE21A
      • TSFAE21B
      • TSFAE21C
      • TSFAE21D
      • TSFAE22A
      • TSFAE22B
      • TSFAE22C
      • TSFAE23A
      • TSFAE23B
      • TSFAE23C
      • TSFAE23D
      • TSFAE24A
      • TSFAE24B
      • TSFAE24C
      • TSFAE24D
      • TSFAE24F
      • TSFDTH01
    • Clinical Laboratory Evaluation
      • TSFLAB01
      • TSFLAB01A
      • TSFLAB02
      • TSFLAB02A
      • TSFLAB02B
      • TSFLAB03
      • TSFLAB03A
      • TSFLAB04A
      • TSFLAB04B
      • TSFLAB05
      • TSFLAB06
      • TSFLAB07
    • Demographic
      • TSIDEM01
      • TSIDEM02
      • TSIMH01
    • Disposition of Subjects
      • TSIDS01
      • TSIDS02
      • TSIDS02A
    • Electrocardiograms
      • TSFECG01
      • TSFECG01A
      • TSFECG02
      • TSFECG03
      • TSFECG04
      • TSFECG05
    • Exposure
      • TSIEX01
      • TSIEX02
      • TSIEX03
      • TSIEX04
      • TSIEX06
      • TSIEX07
      • TSIEX08
      • TSIEX09
      • TSIEX10
      • TSIEX11
    • Pharmacokinetics
      • TPK01A
      • TPK01B
      • TPK02
      • TPK03
    • Prior and Concomitant Therapies
      • TSICM01
      • TSICM02
      • TSICM03
      • TSICM04
      • TSICM05
      • TSICM06
      • TSICM07
      • TSICM08
    • Vital Signs and Physical Findings
      • TSFVIT01
      • TSFVIT01A
      • TSFVIT02
      • TSFVIT03
      • TSFVIT04
      • TSFVIT05
      • TSFVIT06
  • Listings
    • Adverse Events
      • LSFAE01
      • LSFAE02
      • LSFAE03
      • LSFAE04
      • LSFAE05
      • LSFAE06A
      • LSFAE06B
      • LSFDTH01
    • Clinical Laboratory Evaluation
      • LSFLAB01
    • Demographic
      • LSIDEM01
      • LSIDEM02
      • LSIMH01
    • Disposition of Subjects
      • LSIDS01
      • LSIDS02
      • LSIDS03
      • LSIDS04
      • LSIDS05
    • Electrocardiograms
      • LSFECG01
      • LSFECG02
    • Exposure
      • LSIEX01
      • LSIEX02
      • LSIEX03
    • Prior and Concomitant Therapies
      • LSICM01
    • Vital Signs and Physical Findings
      • LSFVIT01
      • LSFVIT02

  • Reproducibility

  • Changelog

On this page

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  1. Listings
  2. Exposure
  3. LSIEX01

LSIEX01

Listing of Study Treatment Administration


Output

  • Preview
Code
# Program Name:              lsiex01.R

# Prep environment

library(envsetup)
library(tern)
library(dplyr)
library(rtables)
library(rlistings)
library(junco)

# Define script level parameters

tblid <- "LSIEX01"
fileid <- tblid
popfl <- "SAFFL"
trtvar <- "TRT01A"
key_cols <- c("COL0", "COL1", "COL2")
disp_cols <- paste0("COL", 0:10)
concat_sep <- " / "
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map

# Process data

adex <- pharmaverseadamjnj::adex %>%
  filter(!!rlang::sym(popfl) == "Y")

lsting <- adex %>%
  mutate(
    AGE = explicit_na(as.character(AGE), ""),
    SEX = explicit_na(SEX, ""),
    RACE_DECODE = explicit_na(RACE_DECODE, ""),
    ASTDT = ifelse(
      !is.na(ASTDT) & nchar(as.character(ASTDT)) == 10,
      toupper(format(ASTDT, "%d%b%Y")),
      ""
    ),
    ASTTM = ifelse(!is.na(ASTDTM), substr(as.character(ASTDTM), 12, 16), ""),
    ASTDYN = ifelse(!is.na(ASTDY), ASTDY, NA),
    ASTDY = ifelse(!is.na(ASTDY), ASTDY, ""),
    AENDT = ifelse(
      !is.na(AENDT) & nchar(as.character(AENDT)) == 10,
      toupper(format(AENDT, "%d%b%Y")),
      ""
    ),
    AENTM = ifelse(!is.na(AENDTM), substr(as.character(AENDTM), 12, 16), ""),
    AENDY = ifelse(!is.na(AENDY), AENDY, ""),
    AREASOC = explicit_na(AREASOC, ""),
    AREASOO = explicit_na(AREASOO, ""),
    AADJ = explicit_na(AADJ, ""),
    AADJOTH = explicit_na(AADJOTH, ""),
    COL0 = explicit_na(.data[[trtvar]], ""),
    COL1 = explicit_na(USUBJID, ""),
    COL2 = paste(AGE, SEX, RACE_DECODE, sep = concat_sep),
    # Optional Column: COL3/AVISIT
    COL3 = explicit_na(AVISIT, ""),
    # Optional Column: COL4/ASCHDOSE/ASCHDOSU
    COL4 = ifelse(is.na(ASCHDOSE), "", paste(ASCHDOSE, ASCHDOSU)),
    COL5 = ifelse(is.na(ADOSE), "", paste(ADOSE, ADOSU)),
    # Optional Column: COL6/ADOSFRM/ADOSFRQ/AROUTE
    COL6 = paste(
      stringr::str_to_sentence(ADOSFRM),
      ADOSFRQ,
      stringr::str_to_sentence(AROUTE),
      sep = concat_sep
    ),
    # Optional Variable: ASTTM
    COL7 = case_when(
      ASTDT == "" ~ "",
      ASTDT != "" & ASTTM != "" & ASTDY != "" ~
        paste0(ASTDT, concat_sep, ASTTM, " (", ASTDY, ")"),
      ASTDT != "" & ASTTM == "" & ASTDY != "" ~
        paste0(ASTDT, concat_sep, "--:--", " (", ASTDY, ")"),
      ASTDT != "" & ASTTM != "" & ASTDY == "" ~
        paste0(ASTDT, concat_sep, ASTTM, " (-)"),
      ASTDT != "" & ASTTM == "" & ASTDY == "" ~
        paste0(ASTDT, concat_sep, "--:--", " (-)"),
    ),
    # Optional Variable: AENTM
    COL8 = case_when(
      AENDT == "" ~ "",
      AENDT != "" & AENTM != "" & AENDY != "" ~
        paste0(AENDT, concat_sep, AENTM, " (", AENDY, ")"),
      AENDT != "" & AENTM == "" & AENDY != "" ~
        paste0(AENDT, concat_sep, "--:--", " (", AENDY, ")"),
      AENDT != "" & AENTM != "" & AENDY == "" ~
        paste0(AENDT, concat_sep, AENTM, " (-)"),
      AENDT != "" & AENTM == "" & AENDY == "" ~
        paste0(AENDT, concat_sep, "--:--", " (-)"),
    ),
    # Optional Column: COL9/AREASOC/AREASOO
    COL9 = case_when(
      toupper(AREASOC) == "OTHER" ~
        paste(
          stringr::str_to_sentence(AREASOC),
          stringr::str_to_sentence(AREASOO),
          sep = ": "
        ),
      !is.na(AREASOC) ~ stringr::str_to_sentence(AREASOC),
      is.na(AREASOC) ~ ""
    ),
    # Optional Column: COL10/AADJ/AADJOTH
    COL10 = case_when(
      toupper(AADJ) == "OTHER" ~
        paste(
          stringr::str_to_sentence(AADJ),
          stringr::str_to_sentence(AADJOTH),
          sep = ": "
        ),
      !is.na(AADJ) ~ stringr::str_to_sentence(AADJ),
      is.na(AADJ) ~ ""
    )
  ) %>%
  arrange(COL0, COL1, COL2, !is.na(ASTDYN), ASTDYN, ASTDTM, AVISITN)

lsting <- var_relabel(
  lsting,
  COL0 = "Treatment Group",
  COL1 = "Subject ID",
  COL2 = paste("Age (years)", "Sex", "Race", sep = concat_sep),
  # Optional Column: COL3/AVISIT
  COL3 = "Visit",
  # Optional Column: COL4/ASCHDOSE/ASCHDOSU
  COL4 = "Prescribed Dose Level (unit)",
  COL5 = "Dose (unit)",
  # Optional Column: COL6/ADOSFRM/ADOSFRQ/AROUTE
  COL6 = paste("Formulation", "Frequency", "Route", sep = concat_sep),
  # Optional Variable: ASTTM
  COL7 = paste("Start Date", "Time (Study Day~[super a])", sep = concat_sep),
  # Optional Variable: AENTM
  COL8 = paste("End Date", "Time (Study Day~[super a])", sep = concat_sep),
  # Optional Column: COL9/AREASOC/AREASOO
  COL9 = "Reason Dose Not Administered, if Applicable",
  # Optional Column: COL10/AADJ/AADJOTH
  COL10 = "Reason Dose Adjusted, if Applicable"
)

# Build listing

result <- rlistings::as_listing(
  df = lsting,
  key_cols = key_cols,
  disp_cols = disp_cols
)

# Add titles and footnotes

result <- set_titles(result, tab_titles)

# Output listing

tt_to_tlgrtf(string_map = string_map, tt = head(result, 100), file = fileid, orientation = "landscape")

LSIEX01: Listing of Study Treatment Administration; Safety Analysis Set (Study jjcs - core)

Treatment Group

Subject ID

Age (years) / Sex / Race

Visit

Prescribed Dose Level (unit)

Dose (unit)

Formulation / Frequency / Route

Start Date / Time (Study Daya)

End Date / Time (Study Daya)

Reason Dose Not Administered, if Applicable

Reason Dose Adjusted, if Applicable

Xanomeline High Dose

01-701-1028

71 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

19JUL2013 / 03:00 (1)

01AUG2013 / --:-- (14)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

02AUG2013 / 10:00 (15)

06JAN2014 / --:-- (172)

WEEK 24

7.5 mg

300 mg

Patch / QD / Transdermal

07JAN2014 / 11:00 (173)

14JAN2014 / --:-- (180)

01-701-1034

77 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

01JUL2014 / 17:00 (1)

15JUL2014 / --:-- (15)

WEEK 2

0 mg

60 mg

Patch / QD / Transdermal

16JUL2014 / 10:00 (16)

17DEC2014 / --:-- (170)

Adverse event

Adverse event

WEEK 24

0 mg

60 mg

Patch / QD / Transdermal

18DEC2014 / 07:00 (171)

30DEC2014 / --:-- (183)

Adverse event

Adverse event

01-701-1133

81 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

28OCT2012 / 08:00 (1)

12NOV2012 / --:-- (16)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

13NOV2012 / 08:00 (17)

18APR2013 / --:-- (173)

WEEK 24

7.5 mg

480 mg

Patch / QD / Transdermal

19APR2013 / 00:00 (174)

28APR2013 / --:-- (183)

01-701-1146

75 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

20MAY2013 / 17:00 (1)

03JUN2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

04JUN2013 / 05:00 (16)

26JUN2013 / --:-- (38)

01-701-1148

57 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

23AUG2013 / 01:00 (1)

05SEP2013 / --:-- (14)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

06SEP2013 / 12:00 (15)

08FEB2014 / --:-- (170)

WEEK 24

0 mg

60 mg

Patch / QD / Transdermal

09FEB2014 / 10:00 (171)

20FEB2014 / --:-- (182)

Other: Other reason

Other: Sheet could not into the bladder

01-701-1180

56 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

12FEB2013 / 02:00 (1)

25FEB2013 / --:-- (14)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

26FEB2013 / 04:00 (15)

18MAR2013 / --:-- (35)

01-701-1239

56 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

11JAN2014 / 05:00 (1)

25JAN2014 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

26JAN2014 / 05:00 (16)

27JUN2014 / --:-- (168)

WEEK 24

7.5 mg

480 mg

Patch / QD / Transdermal

28JUN2014 / 15:00 (169)

10JUL2014 / --:-- (181)

01-701-1275

61 / Male / American Indian or Alaska Native

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

07FEB2014 / 00:00 (1)

22FEB2014 / --:-- (16)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

23FEB2014 / 02:00 (17)

31MAY2014 / --:-- (114)

01-701-1287

56 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

25JAN2014 / 22:00 (1)

11FEB2014 / --:-- (18)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

12FEB2014 / 22:00 (19)

12JUL2014 / --:-- (169)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

13JUL2014 / 18:00 (170)

26JUL2014 / --:-- (183)

01-701-1302

61 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

29AUG2013 / 03:00 (1)

15SEP2013 / --:-- (18)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

16SEP2013 / 20:00 (19)

05NOV2013 / --:-- (69)

01-701-1383

72 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

04FEB2013 / 16:00 (1)

19FEB2013 / --:-- (16)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

20FEB2013 / 01:00 (17)

30JUL2013 / --:-- (177)

WEEK 24

7.5 mg

300 mg

Patch / QD / Transdermal

31JUL2013 / 07:00 (178)

06AUG2013 / --:-- (184)

01-701-1444

63 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

05JAN2013 / 09:00 (1)

18JAN2013 / --:-- (14)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

19JAN2013 / 16:00 (15)

12FEB2013 / --:-- (39)

01-703-1076

69 / Male / White

BASELINE

7.5 mg

480 mg

Patch / QD / Transdermal

25OCT2013 / 16:00 (1)

06NOV2013 / --:-- (13)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

07NOV2013 / 05:00 (14)

24DEC2013 / --:-- (61)

01-703-1258

78 / Female / White

BASELINE

7.5 mg

480 mg

Patch / QD / Transdermal

20JUL2012 / 05:00 (1)

01AUG2012 / --:-- (13)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

02AUG2012 / 18:00 (14)

31DEC2012 / --:-- (165)

WEEK 24

7.5 mg

480 mg

Patch / QD / Transdermal

01JAN2013 / 17:00 (166)

11JAN2013 / --:-- (176)

01-703-1295

88 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

21NOV2013 / 13:00 (1)

05DEC2013 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

06DEC2013 / 05:00 (16)

19APR2014 / --:-- (150)

01-703-1335

67 / Female / Black or African American

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

17MAR2014 / 10:00 (1)

31MAR2014 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

01APR2014 / 16:00 (16)

07MAY2014 / --:-- (52)

01-703-1439

76 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

12MAR2014 / 11:00 (1)

26MAR2014 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

27MAR2014 / 12:00 (16)

28AUG2014 / --:-- (170)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

29AUG2014 / 17:00 (171)

11SEP2014 / --:-- (184)

01-704-1008

76 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

13JAN2013 / 16:00 (1)

28JAN2013 / --:-- (16)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

29JAN2013 / 00:00 (17)

21FEB2013 / --:-- (40)

01-704-1017

77 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

06OCT2013 / 00:00 (1)

19OCT2013 / --:-- (14)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

20OCT2013 / 17:00 (15)

18NOV2013 / --:-- (44)

01-704-1065

75 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

24OCT2013 / 21:00 (1)

07NOV2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

08NOV2013 / 01:00 (16)

22DEC2013 / --:-- (60)

01-704-1074

80 / Female / White

BASELINE

7.5 mg

960 mg

Patch / QD / Transdermal

22JAN2014 / 20:00 (1)

09FEB2014 / --:-- (19)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

10FEB2014 / 09:00 (20)

20MAR2014 / --:-- (58)

01-704-1093

79 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

15MAR2013 / 10:00 (1)

30MAR2013 / --:-- (16)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

31MAR2013 / 07:00 (17)

17JUN2013 / --:-- (95)

01-704-1241

86 / Male / White

BASELINE

7.5 mg

480 mg

Patch / QD / Transdermal

25AUG2013 / 19:00 (1)

05SEP2013 / --:-- (12)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

06SEP2013 / 08:00 (13)

09OCT2013 / --:-- (46)

01-704-1266

82 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

13OCT2013 / 20:00 (1)

27OCT2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

28OCT2013 / 11:00 (16)

06DEC2013 / --:-- (55)

01-704-1332

80 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

09DEC2013 / 11:00 (1)

23DEC2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

24DEC2013 / 06:00 (16)

14FEB2014 / --:-- (68)

01-705-1280

56 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

17JAN2014 / 01:00 (1)

31JAN2014 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

01FEB2014 / 22:00 (16)

11JUL2014 / --:-- (176)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

12JUL2014 / 01:00 (177)

25JUL2014 / --:-- (190)

01-705-1281

73 / Female / Black or African American

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

28NOV2013 / 00:00 (1)

15DEC2013 / --:-- (18)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

16DEC2013 / 07:00 (19)

27FEB2014 / --:-- (92)

01-705-1303

72 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

16DEC2013 / 12:00 (1)

30DEC2013 / --:-- (15)

WEEK 2

15 mg

Patch / QD / Transdermal

31DEC2013 / 22:00 (16)

01-705-1310

74 / Female / White

BASELINE

7.5 mg

960 mg

Patch / QD / Transdermal

02NOV2013 / 13:00 (1)

22NOV2013 / --:-- (21)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

23NOV2013 / 23:00 (22)

23JAN2014 / --:-- (83)

01-705-1377

63 / Female / Black or African American

BASELINE

7.5 mg

960 mg

Patch / QD / Transdermal

04JAN2014 / 08:00 (1)

25JAN2014 / --:-- (22)

WEEK 2

15 mg

Patch / QD / Transdermal

26JAN2014 / 21:00 (23)

01-706-1049

60 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

14MAY2013 / 01:00 (1)

28MAY2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

29MAY2013 / 01:00 (16)

18JUN2013 / --:-- (36)

01-708-1178

77 / Female / Black or African American

BASELINE

7.5 mg

960 mg

Patch / QD / Transdermal

29DEC2013 / 16:00 (1)

18JAN2014 / --:-- (21)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

19JAN2014 / 23:00 (22)

06APR2014 / --:-- (99)

01-708-1216

78 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

24OCT2012 / 08:00 (1)

08NOV2012 / --:-- (16)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

09NOV2012 / 05:00 (17)

29NOV2012 / --:-- (37)

01-708-1336

73 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

07DEC2012 / 03:00 (1)

21DEC2012 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

22DEC2012 / 09:00 (16)

22MAY2013 / --:-- (167)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

23MAY2013 / 18:00 (168)

05JUN2013 / --:-- (181)

01-708-1347

61 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

20APR2013 / 07:00 (1)

04MAY2013 / --:-- (15)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

05MAY2013 / 19:00 (16)

18JUN2013 / --:-- (60)

01-708-1406

71 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

26DEC2013 / 15:00 (1)

09JAN2014 / --:-- (15)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

10JAN2014 / 12:00 (16)

16JUN2014 / --:-- (173)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

17JUN2014 / 11:00 (174)

02JUL2014 / --:-- (189)

01-709-1029

82 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

25DEC2012 / 05:00 (1)

09JAN2013 / --:-- (16)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

10JAN2013 / 04:00 (17)

12JUN2013 / --:-- (170)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

13JUN2013 / 01:00 (171)

26JUN2013 / --:-- (184)

01-709-1099

79 / Female / White

BASELINE

7.5 mg

960 mg

Patch / QD / Transdermal

25OCT2013 / 03:00 (1)

12NOV2013 / --:-- (19)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

13NOV2013 / 03:00 (20)

11APR2014 / --:-- (169)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

12APR2014 / 09:00 (170)

25APR2014 / --:-- (183)

01-709-1168

72 / Female / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

02AUG2013 / 13:00 (1)

17AUG2013 / --:-- (16)

WEEK 2

15 mg

960 mg

Patch / QD / Transdermal

18AUG2013 / 03:00 (17)

26SEP2013 / --:-- (56)

01-709-1238

69 / Male / White

BASELINE

7.5 mg

720 mg

Patch / QD / Transdermal

15MAY2013 / 05:00 (1)

29MAY2013 / --:-- (15)

WEEK 2

15 mg

1800 mg

Patch / QD / Transdermal

30MAY2013 / 16:00 (16)

06AUG2013 / --:-- (84)

01-709-1309

65 / Male / White

BASELINE

7.5 mg

480 mg

Patch / QD / Transdermal

19JUN2013 / 13:00 (1)

01JUL2013 / --:-- (13)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

02JUL2013 / 19:00 (14)

05DEC2013 / --:-- (170)

WEEK 24

7.5 mg

720 mg

Patch / QD / Transdermal

06DEC2013 / 16:00 (171)

19DEC2013 / --:-- (184)

01-710-1006

77 / Male / White

BASELINE

7.5 mg

480 mg

Patch / QD / Transdermal

10FEB2013 / 07:00 (1)

22FEB2013 / --:-- (13)

WEEK 2

15 mg

3600 mg

Patch / QD / Transdermal

23FEB2013 / 02:00 (14)

27JUL2013 / --:-- (168)

WEEK 24

7.5 mg

480 mg

Patch / QD / Transdermal

28JUL2013 / 05:00 (169)

09AUG2013 / --:-- (181)

a Study day is relative to [the start of [study treatment]].

[lsiex01.docx][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2026, 16:07

Download RTF file

LSFECG02
LSIEX02
Source Code
---
title: LSIEX01
subtitle: Listing of Study Treatment Administration
---

------------------------------------------------------------------------

{{< include ../../_utils/envir_hook.qmd >}}

```{r setup, echo = FALSE, warning = FALSE, message = FALSE}
options(docx.add_datetime = FALSE, tidytlg.add_datetime = FALSE)
envsetup_config_name <- "default"

# Path to the combined config file
envsetup_file_path <- file.path("../..", "envsetup.yml")

Sys.setenv(ENVSETUP_ENVIRON = '')
library(envsetup)
loaded_config <- config::get(config = envsetup_config_name, file = envsetup_file_path)
envsetup::rprofile(loaded_config)


dpscomp <- compound
dpspdr <- paste(protocol,dbrelease,rpteff,sep="__")

aptcomp <- compound
aptpdr <- paste(protocol,dbrelease,rpteff,sep="__")

###### Study specific updates (formerly in envre)

dpscomp <- "standards"
dpspdr <- "jjcs__NULL__jjcs - core"

apt <- FALSE
library(junco)
default_str_map <- rbind(default_str_map, c("&ctcae", "5.0"))

```

## Output

:::: panel-tabset
## {{< fa regular file-lines sm fw >}} Preview

```{r variant1, results='hide', warning = FALSE, message = FALSE}

# Program Name:              lsiex01.R

# Prep environment

library(envsetup)
library(tern)
library(dplyr)
library(rtables)
library(rlistings)
library(junco)

# Define script level parameters

tblid <- "LSIEX01"
fileid <- tblid
popfl <- "SAFFL"
trtvar <- "TRT01A"
key_cols <- c("COL0", "COL1", "COL2")
disp_cols <- paste0("COL", 0:10)
concat_sep <- " / "
tab_titles <- get_titles_from_file(input_path = '../../_data/', tblid)
string_map <- default_str_map

# Process data

adex <- pharmaverseadamjnj::adex %>%
  filter(!!rlang::sym(popfl) == "Y")

lsting <- adex %>%
  mutate(
    AGE = explicit_na(as.character(AGE), ""),
    SEX = explicit_na(SEX, ""),
    RACE_DECODE = explicit_na(RACE_DECODE, ""),
    ASTDT = ifelse(
      !is.na(ASTDT) & nchar(as.character(ASTDT)) == 10,
      toupper(format(ASTDT, "%d%b%Y")),
      ""
    ),
    ASTTM = ifelse(!is.na(ASTDTM), substr(as.character(ASTDTM), 12, 16), ""),
    ASTDYN = ifelse(!is.na(ASTDY), ASTDY, NA),
    ASTDY = ifelse(!is.na(ASTDY), ASTDY, ""),
    AENDT = ifelse(
      !is.na(AENDT) & nchar(as.character(AENDT)) == 10,
      toupper(format(AENDT, "%d%b%Y")),
      ""
    ),
    AENTM = ifelse(!is.na(AENDTM), substr(as.character(AENDTM), 12, 16), ""),
    AENDY = ifelse(!is.na(AENDY), AENDY, ""),
    AREASOC = explicit_na(AREASOC, ""),
    AREASOO = explicit_na(AREASOO, ""),
    AADJ = explicit_na(AADJ, ""),
    AADJOTH = explicit_na(AADJOTH, ""),
    COL0 = explicit_na(.data[[trtvar]], ""),
    COL1 = explicit_na(USUBJID, ""),
    COL2 = paste(AGE, SEX, RACE_DECODE, sep = concat_sep),
    # Optional Column: COL3/AVISIT
    COL3 = explicit_na(AVISIT, ""),
    # Optional Column: COL4/ASCHDOSE/ASCHDOSU
    COL4 = ifelse(is.na(ASCHDOSE), "", paste(ASCHDOSE, ASCHDOSU)),
    COL5 = ifelse(is.na(ADOSE), "", paste(ADOSE, ADOSU)),
    # Optional Column: COL6/ADOSFRM/ADOSFRQ/AROUTE
    COL6 = paste(
      stringr::str_to_sentence(ADOSFRM),
      ADOSFRQ,
      stringr::str_to_sentence(AROUTE),
      sep = concat_sep
    ),
    # Optional Variable: ASTTM
    COL7 = case_when(
      ASTDT == "" ~ "",
      ASTDT != "" & ASTTM != "" & ASTDY != "" ~
        paste0(ASTDT, concat_sep, ASTTM, " (", ASTDY, ")"),
      ASTDT != "" & ASTTM == "" & ASTDY != "" ~
        paste0(ASTDT, concat_sep, "--:--", " (", ASTDY, ")"),
      ASTDT != "" & ASTTM != "" & ASTDY == "" ~
        paste0(ASTDT, concat_sep, ASTTM, " (-)"),
      ASTDT != "" & ASTTM == "" & ASTDY == "" ~
        paste0(ASTDT, concat_sep, "--:--", " (-)"),
    ),
    # Optional Variable: AENTM
    COL8 = case_when(
      AENDT == "" ~ "",
      AENDT != "" & AENTM != "" & AENDY != "" ~
        paste0(AENDT, concat_sep, AENTM, " (", AENDY, ")"),
      AENDT != "" & AENTM == "" & AENDY != "" ~
        paste0(AENDT, concat_sep, "--:--", " (", AENDY, ")"),
      AENDT != "" & AENTM != "" & AENDY == "" ~
        paste0(AENDT, concat_sep, AENTM, " (-)"),
      AENDT != "" & AENTM == "" & AENDY == "" ~
        paste0(AENDT, concat_sep, "--:--", " (-)"),
    ),
    # Optional Column: COL9/AREASOC/AREASOO
    COL9 = case_when(
      toupper(AREASOC) == "OTHER" ~
        paste(
          stringr::str_to_sentence(AREASOC),
          stringr::str_to_sentence(AREASOO),
          sep = ": "
        ),
      !is.na(AREASOC) ~ stringr::str_to_sentence(AREASOC),
      is.na(AREASOC) ~ ""
    ),
    # Optional Column: COL10/AADJ/AADJOTH
    COL10 = case_when(
      toupper(AADJ) == "OTHER" ~
        paste(
          stringr::str_to_sentence(AADJ),
          stringr::str_to_sentence(AADJOTH),
          sep = ": "
        ),
      !is.na(AADJ) ~ stringr::str_to_sentence(AADJ),
      is.na(AADJ) ~ ""
    )
  ) %>%
  arrange(COL0, COL1, COL2, !is.na(ASTDYN), ASTDYN, ASTDTM, AVISITN)

lsting <- var_relabel(
  lsting,
  COL0 = "Treatment Group",
  COL1 = "Subject ID",
  COL2 = paste("Age (years)", "Sex", "Race", sep = concat_sep),
  # Optional Column: COL3/AVISIT
  COL3 = "Visit",
  # Optional Column: COL4/ASCHDOSE/ASCHDOSU
  COL4 = "Prescribed Dose Level (unit)",
  COL5 = "Dose (unit)",
  # Optional Column: COL6/ADOSFRM/ADOSFRQ/AROUTE
  COL6 = paste("Formulation", "Frequency", "Route", sep = concat_sep),
  # Optional Variable: ASTTM
  COL7 = paste("Start Date", "Time (Study Day~[super a])", sep = concat_sep),
  # Optional Variable: AENTM
  COL8 = paste("End Date", "Time (Study Day~[super a])", sep = concat_sep),
  # Optional Column: COL9/AREASOC/AREASOO
  COL9 = "Reason Dose Not Administered, if Applicable",
  # Optional Column: COL10/AADJ/AADJOTH
  COL10 = "Reason Dose Adjusted, if Applicable"
)

# Build listing

result <- rlistings::as_listing(
  df = lsting,
  key_cols = key_cols,
  disp_cols = disp_cols
)

# Add titles and footnotes

result <- set_titles(result, tab_titles)

# Output listing

tt_to_tlgrtf(string_map = string_map, tt = head(result, 100), file = fileid, orientation = "landscape")
```
```{r result1, echo=FALSE, message=FALSE, warning=FALSE, test = list(result_v1 = "result")}
tt_to_flextable_j(head(result,100), tblid, string_map = string_map)
```

[Download RTF file](`r paste0(tolower(tblid), '.rtf')`)
::::

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