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Example 8: Patient Profile

Below is an example showing a patient profile report. Every organization has their own way of presenting patient profiles. This is an example of a “master and detail” type of report.

Program

Note the following about this example:

library(sassy)

options("logr.notes" = FALSE,
        "logr.autolog" = TRUE)

# Get temp location for log and report output
tmp <- tempdir()

lf <- log_open(file.path(tmp, "example8.log"))


# Get data ----------------------------------------------------------------
sep("Get data")


# Get sample data path
pth <- system.file("extdata", package = "sassy")

put("Open data library")
libname(sdtm, pth, "csv")


# Set labels --------------------------------------------------------------
sep("Set labels")

put("DM labels")
labels(sdtm$DM) <- list(ARM = "Treatment Group",
                        SITEID = "Centre",
                        SUBJID = "Subject", 
                        SEX = "Sex", 
                        AGE = "Age (yrs)",
                        RACE = "Race", 
                        BRTHDTC = "Birth Date",
                        ARMCD = "Treatment Code"
) |> put()
put("AE labels")
labels(sdtm$AE) <- list(AESTDTC = "Event Start Date",
                        AEENDTC = "Event Stop Date",
                        AESTDY = "Start",
                        AEENDY = "End",
                        AESOC = "System Organ Class",
                        AESEV = "Severityᵃ",
                        AESER = "Serious",
                        AEREL = "Related") |> put()


# Apply formats ----------------------------------------------------------
sep("Apply formats")

sevfmt <- value(condition(x == "MODERATE", "Moderate"),
                condition(x == "SEVERE", "Severe"),
                condition(x == "MILD", "Mild"))


relfmt <- value(condition(x == "RELATED", "Yes"),
                condition(x == "NOT RELATED", "No"),
                condition(x == "PROBABLY RELATED", "Probably"),
                condition(x == "POSSIBLY RELATED", "Possibly")) 

serfmt <- value(condition(x == "N", "No"),
                condition(x == "Y", "Yes")) 


sexfmt <- value(condition(x == "M", "Male"),
                condition(x == "F", "Female"),
                condition(TRUE, "Unknown")) 

racefmt <- value(condition(x == "WHITE", "White"),
                 condition(x == "BLACK OR AFRICAN AMERICAN", "Black"),
                 condition(x == "UNKNOWN", "Unknown"),
                 condition(x == "ASIAN", "Asian")) 

armfmt <- value(condition(x == "ARM A", "Placebo"),
                condition(x == "ARM B", "Dose 50mg"),
                condition(x == "ARM C", "Dose 100mg"),
                condition(x == "ARM D", "Competitor")) 


formats(sdtm$DM) <- list(SEX = sexfmt, 
                         RACE = racefmt,
                         ARM = armfmt)

formats(sdtm$AE) <- list(AESEV = sevfmt,
                         AEREL = relfmt, 
                         AESER = serfmt) 


# Prepare data ------------------------------------------------------------

sep("Prepare data")

put("Select desired columns from DM dataset")
datastep(sdtm$DM, 
         keep = v(USUBJID, ARM, SITEID, SUBJID, SEX, AGE, RACE, BRTHDTC), {}) -> dm 


# Split dm data by subject id
dmlst <- split(dm, factor(dm$USUBJID))

put("Select desired columns from AE dataset")
datastep(sdtm$AE, 
         keep = v(USUBJID, AESTDTC, AEENDTC, AESTDY, 
                  AEENDY, AESOC, AESEV, AESER, AEREL), {}) -> ae

# Split ae data by subject id
aelst <- split(ae, factor(ae$USUBJID))


# Create report -----------------------------------------------------------
sep("Create report")

# Create report first, outside loop
rpt <- create_report(file.path(tmp, "output/example8.docx"), 
                     font = "Arial", output_type = "DOCX")

# Loop on subjects
for (id in names(dmlst)) {
  
  dm_sub <- dmlst[[id]]
  ae_sub <- aelst[[id]]
  
  tb1 <- create_table(dm_sub, width = 8, borders = "outside") |> 
    titles("Listing 1.1 Subjects Narratives of Adverse Events",
           paste0("Subject: ", dm_sub[[1, 1]]), bold = TRUE) |> 
    define(AGE, align = "left")
  
  if (!is.null(ae_sub)) {
    tb2 <- create_table(ae_sub, borders = "outside", width = 8) |> 
      spanning_header("AESTDY", "AEENDY", label ="Study Day") |> 
      define(USUBJID, visible = FALSE) |> 
      define(AESOC, width = 2) |> 
      define(AESTDY, align = "left") |> 
      define(AEENDY, align = "left") |> 
      footnotes("ᵃSeverity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal",
                paste0("ᵇAction Taken: 01=None, 02=Investigational product dose altered, ",
                       "03=Medication taken, 04=Hospitalized, 05=Removed from study, ",
                       "06=Investigational product discontinued, 07=Transfusion performed,",
                       "88=Other"))
  }
  
  # Append table content
  rpt <- rpt |>  add_content(tb1, page_break = FALSE) |> 
    add_content(tb2)
  
}

put("Write out report")
res <- write_report(rpt)


# Clean Up ----------------------------------------------------------------


sep("Clean up")

log_close()


# View log
# file.show(lf)

# View report
# file.show(res$modified_path)

Output

Here is page 11 out of 87 pages in the output report:

Log

Here is most of the log from the above program:

=========================================================================
Log Path: C:/Users/dbosa/AppData/Local/Temp/Rtmp6lCP5X/log/example8.log
Program Path: C:/packages/Testing/procs/ProcsPatientProfile.R
Working Directory: C:/packages/Testing/procs
User Name: dbosa
R Version: 4.3.1 (2023-06-16 ucrt)
Machine: SOCRATES x86-64
Operating System: Windows 10 x64 build 22621
Base Packages: stats graphics grDevices utils datasets methods base Other
Packages: tidylog_1.0.2 ggplot2_3.4.2 patchwork_1.1.3 procs_1.0.3
reporter_1.4.1 libr_1.2.8 fmtr_1.5.9 logr_1.3.4 common_1.0.8 sassy_1.2.0
Log Start Time: 2023-09-06 21:24:18.59308
=========================================================================

=========================================================================
Get data
=========================================================================

# library 'sdtm': 7 items
- attributes: csv not loaded
- path: C:/Users/dbosa/AppData/Local/R/win-library/4.3/sassy/extdata
- items:
  Name Extension Rows Cols     Size        LastModified
1   AE       csv  150   27  88.5 Kb 2023-09-06 21:14:37
2   DM       csv   87   24  45.5 Kb 2023-09-06 21:14:37
3   DS       csv  174    9  34.1 Kb 2023-09-06 21:14:37
4   EX       csv   84   11  26.4 Kb 2023-09-06 21:14:37
5   IE       csv    2   14  13.4 Kb 2023-09-06 21:14:37
6   SV       csv  685   10  70.3 Kb 2023-09-06 21:14:37
7   VS       csv 3358   17 467.4 Kb 2023-09-06 21:14:37

=========================================================================
Set labels
=========================================================================

DM labels

$ARM
[1] "Treatment Group"

$SITEID
[1] "Centre"

$SUBJID
[1] "Subject"

$SEX
[1] "Sex"

$AGE
[1] "Age (yrs)"

$RACE
[1] "Race"

$BRTHDTC
[1] "Birth Date"

$ARMCD
[1] "Treatment Code"


AE labels

$AESTDTC
[1] "Event Start Date"

$AEENDTC
[1] "Event Stop Date"

$AESTDY
[1] "Start"

$AEENDY
[1] "End"

$AESOC
[1] "System Organ Class"

$AESEV
[1] "Severityᵃ"

$AESER
[1] "Serious"

$AEREL
[1] "Related"


=========================================================================
Apply formats
=========================================================================

# A user-defined format: 3 conditions
  Name Type      Expression    Label Order
1  obj    U x == "MODERATE" Moderate    NA
2  obj    U   x == "SEVERE"   Severe    NA
3  obj    U     x == "MILD"     Mild    NA

# A user-defined format: 4 conditions
  Name Type              Expression    Label Order
1  obj    U          x == "RELATED"      Yes    NA
2  obj    U      x == "NOT RELATED"       No    NA
3  obj    U x == "PROBABLY RELATED" Probably    NA
4  obj    U x == "POSSIBLY RELATED" Possibly    NA

# A user-defined format: 2 conditions
  Name Type Expression Label Order
1  obj    U   x == "N"    No    NA
2  obj    U   x == "Y"   Yes    NA

# A user-defined format: 3 conditions
  Name Type Expression   Label Order
1  obj    U   x == "M"    Male    NA
2  obj    U   x == "F"  Female    NA
3  obj    U       TRUE Unknown    NA

# A user-defined format: 4 conditions
  Name Type                       Expression   Label Order
1  obj    U                     x == "WHITE"   White    NA
2  obj    U x == "BLACK OR AFRICAN AMERICAN"   Black    NA
3  obj    U                   x == "UNKNOWN" Unknown    NA
4  obj    U                     x == "ASIAN"   Asian    NA

# A user-defined format: 4 conditions
  Name Type   Expression      Label Order
1  obj    U x == "ARM A"    Placebo    NA
2  obj    U x == "ARM B"  Dose 50mg    NA
3  obj    U x == "ARM C" Dose 100mg    NA
4  obj    U x == "ARM D" Competitor    NA

=========================================================================
Prepare data
=========================================================================

Select desired columns from DM dataset

datastep: columns decreased from 24 to 8

# A tibble: 87 × 8
   USUBJID    ARM   SITEID SUBJID SEX     AGE RACE                      BRTHDTC   
   <chr>      <chr> <chr>  <chr>  <chr> <dbl> <chr>                     <date>    
 1 ABC-01-049 ARM D 01     049    M        39 WHITE                     1966-11-12
 2 ABC-01-050 ARM B 01     050    M        47 WHITE                     1958-12-19
 3 ABC-01-051 ARM A 01     051    M        34 WHITE                     1972-05-02
 4 ABC-01-052 ARM C 01     052    F        45 WHITE                     1961-06-27
 5 ABC-01-053 ARM B 01     053    F        26 WHITE                     1980-04-07
 6 ABC-01-054 ARM D 01     054    M        44 WHITE                     1962-09-13
 7 ABC-01-055 ARM C 01     055    F        47 BLACK OR AFRICAN AMERICAN 1959-06-11
 8 ABC-01-056 ARM A 01     056    M        31 WHITE                     1975-05-02
 9 ABC-01-113 ARM D 01     113    M        74 WHITE                     1932-02-08
10 ABC-01-114 ARM B 01     114    F        72 WHITE                     1934-07-09
# ℹ 77 more rows
# ℹ Use `print(n = ...)` to see more rows

Select desired columns from AE dataset

datastep: columns decreased from 27 to 9

# A tibble: 150 × 9
   USUBJID    AESTDTC    AEENDTC    AESTDY AEENDY AESOC                AESEV AESER AEREL
   <chr>      <chr>      <chr>       <dbl>  <dbl> <chr>                <chr> <chr> <chr>
 1 ABC-01-049 2006-12-28 2007-03-13     52    127 Investigations       MODE… N     NOT …
 2 ABC-01-049 2006-12-28 2007-03-13     52    127 Investigations       MODE… N     NOT …
 3 ABC-01-049 2007       2007           NA     NA Nervous system diso… MILD  N     NOT …
 4 ABC-01-049 2007-01-11 2007-03-13     66    127 Investigations       MODE… N     NOT …
 5 ABC-01-049 2007       2007           NA     NA Musculoskeletal and… MILD  N     NOT …
 6 ABC-01-050 2006-11-08 2006-11-15      7     14 Skin and subcutaneo… MILD  N     NOT …
 7 ABC-01-050 2006-12-17 2006-12-17     46     46 Respiratory, thorac… MILD  N     NOT …
 8 ABC-01-051 2007-01-01 2007-01-01     61     61 Nervous system diso… MILD  N     NOT …
 9 ABC-01-051 2007-03-06 2007-03-09    125    128 Nervous system diso… MILD  N     NOT …
10 ABC-01-051 2007-11-12 2007-11-14    376    378 Nervous system diso… MILD  N     NOT …
# ℹ 140 more rows
# ℹ Use `print(n = ...)` to see more rows

=========================================================================
Create report
=========================================================================

Write out report

# A report specification: 87 pages
- file_path: 'C:\Users\dbosa\AppData\Local\Temp\Rtmp6lCP5X/output/example8.docx'
- output_type: DOCX
- units: inches
- orientation: landscape
- margins: top 0.5 bottom 0.5 left 1 right 1
- line size/count: 9/42
- content: 
# A table specification:
- data: tibble 'dm_sub' 1 rows 8 cols
- show_cols: all
- use_attributes: all
- width: 8
- title 1: 'Listing 1.1 Subjects Narratives of Adverse Events'
- title 2: 'Subject: ABC-01-049'
- define: AGE align='left' 
# A table specification:
- data: tibble 'ae_sub' 5 rows 9 cols
- show_cols: all
- use_attributes: all
- width: 8
- footnote 1: 'ᵃSeverity: 01=Mild, 02=Moderate, 03=Severe, 04=Life Threatening, 05=Fatal'
- footnote 2: 'ᵇAction Taken: 01=None, 02=Investigational product dose altered, 03=Medication taken, 04=Hospitalized, 05=Removed from study, 06=Investigational product discontinued, 07=Transfusion performed,88=Other'
- spanning_header: from='AESTDY' to='AEENDY' 'Study Day' level=1 
- define: USUBJID visible='FALSE' 
- define: AESOC width=2 
- define: AESTDY align='left' 
- define: AEENDY align='left' 
...

=========================================================================
Clean up
=========================================================================

=========================================================================
Log End Time: 2023-09-06 21:24:25.764916
Log Elapsed Time: 0 00:00:07
=========================================================================

Next: Example 9: Forest Plot

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.