Make Clinical Reporting Easier

Enhancing gtsummary/analysis result dataset with reporter

Xiecheng Gu

2026-03-24

Pain Points in Clinical Reporting

Common challenges

Previous tools were hard to customize for complex clinical tables
Precise layout control (indentation, headers, spanning, pagination) was limited vs. SAS
User-friendly open-source options for ARD-based output were limited

Goal: Make output generation easier, with submission-ready code and future ARD-submission readiness.

gtsummary / crane / cardinal

gtsummary / crane / cardinal strengths

Flexible and highly customizable table content
Strong integration with ARD via cards/cardx; ARD can be generated easily
Easy stacking, merging, and table-body customization
Good for defining what should be shown

Current limitation

Output control is weaker for highly customized RTF/TXT needs
There are still not enough options for fine-grained format control compared with SAS

reporter

reporter strengths

Better control of final report layout
Native focus on TXT / RTF output
As part of SASSY, it inherits the core reporting ideas of SAS PROC REPORT
Easier control of widths, spanning, indentation, pagination, and repeated labels
Good for defining how the report should look

Together: a complete solution

From two pieces to one pipeline

gtsummary / crane / cardinal
What should be in the table

reporter
How the report should look (TXT / RTF)

Together: ARD-friendly table content + SAS-style layout control → a practical, submission-ready reporting path.

Three Output Paths

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flowchart LR
    subgraph Path1["Path 1"]
        D1[Data] --> F1[gtsummary / crane / cardinal<br/>functions]
        F1 --> GO1[gtsummary<br/>object]
        GO1 -.->|gather_ard| ARD1[ARD]
        GO1 --> R1[reporter]
    end
    
    subgraph Path2["Path 2"]
        D2[Data] --> A2[cards / cardx<br/>or custom ARD]
        A2 --> F2[tbl_ard_*<br/>functions]
        F2 --> GO2[gtsummary<br/>object]
        GO2 --> R2[reporter]
    end
    
    subgraph Path3["Path 3"]
        D3[Data] --> A3[cards / cardx<br/>or custom ARD]
        A3 --> DM[data manipulation<br/>for final layout]
        DM --> R3[reporter]
    end
    
    R1 --> OUT[RTF<br/>/ TXT]
    R2 --> OUT
    R3 --> OUT
    
    style D1 fill:#414558,stroke:#8be9fd,color:#ffffff
    style D2 fill:#414558,stroke:#8be9fd,color:#ffffff
    style D3 fill:#414558,stroke:#8be9fd,color:#ffffff
    style F1 fill:#50fa7b,stroke:#44475a,color:#111111
    style F2 fill:#50fa7b,stroke:#44475a,color:#111111
    style GO1 fill:#8be9fd,stroke:#44475a,color:#111111
    style GO2 fill:#8be9fd,stroke:#44475a,color:#111111
    style ARD1 fill:#ffb86c,stroke:#44475a,color:#111111
    style A2 fill:#ffb86c,stroke:#44475a,color:#111111
    style A3 fill:#ffb86c,stroke:#44475a,color:#111111
    style DM fill:#f1fa8c,stroke:#44475a,color:#111111
    style R1 fill:#bd93f9,stroke:#44475a,color:#111111
    style R2 fill:#bd93f9,stroke:#44475a,color:#111111
    style R3 fill:#bd93f9,stroke:#44475a,color:#111111
    style OUT fill:#ff79c6,stroke:#44475a,color:#111111

Together, these three approaches cover nearly every table-output use case

Choosing the Path

Use Path 1 when gtsummary/crane/cardinal already matches the target layout
Use Path 2 when ARD-based construction is needed for enough flexibility to build the desired table layout
Use Path 3 when gtsummary is not flexible enough for the final display

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flowchart TD
    D[Data] --> P{Choose Path}
    P --> P1[Path 1]
    P --> P2[Path 2]
    P --> P3[Path 3]
    P1 --> O[Output]
    P2 --> O
    P3 --> O

How We Build Template Code

1. SETUP

# Configuration
by_var <- "TRT01A"
hierarchy_vars <- c("AESOC", "AEDECOD")

# Data manipulation
adsl <- adsl00 |> filter(SAFFL == "Y")
adae <- adae00 |> filter(TRTEMFL == "Y")

2. BUILD

Path 1: gtsummary / crane / cardinal
Path 2: ARD -> gtsummary
Path 3: ARD -> custom output

3. REPORT

reporter generates final output from data.frame-based structures
gtsummary_to_reporter_clinical() is built on reporter to automatically translate gtsummary styling into reporter output

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flowchart TD

    S["1. SETUP\nConfiguration\ndata preparation"] --> B["2. BUILD\nPath 1: gtsummary / crane\nPath 2: ARD -> gtsummary\nPath 3: ARD -> custom output"]
    B --> R["3. REPORT\ngtsummary_to_reporter_clinical()\nor reporter"]

    style S fill:#1f6f8b,stroke:#8be9fd,stroke-width:2px,color:#ffffff
    style B fill:#2e7d32,stroke:#50fa7b,stroke-width:2px,color:#ffffff
    style R fill:#6a1b9a,stroke:#bd93f9,stroke-width:2px,color:#ffffff

How reporter converts gtsummary to TXT/RTF

Pipeline (same object throughout)

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  "themeVariables": {
    "fontSize": "15px",
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  }
}}%%
flowchart TD
    G["gtsummary object<br/>table_body + table_styling"] --> P["Parse structure<br/>labels, indent, headers, spans"]
    P --> M["Map to reporter<br/>define() + layout rules"]
    M --> R["create_report()<br/>report object"]
    R --> O["TXT / RTF output"]

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    style P fill:#2e7d32,stroke:#50fa7b,stroke-width:3px,color:#ffffff
    style M fill:#6a1b9a,stroke:#bd93f9,stroke-width:3px,color:#ffffff
    style R fill:#a85d00,stroke:#ffb86c,stroke-width:3px,color:#ffffff
    style O fill:#7f1d1d,stroke:#ff79c6,stroke-width:3px,color:#ffffff

1. Object

The printed table does not match the internal layout.

table_body and table_styling carry what we export.

class(tbl)

[1] "tbl_hierarchical" "gtsummary"

names(tbl)

[1] "table_body"    "table_styling" "call_list"     "cards"        
[5] "inputs"

tbl$table_body |>
  dplyr::select(label, row_type, variable, stat_1) |>
  head(8)

# A tibble: 8 × 4
  label                                                row_type variable  stat_1
  <chr>                                                <chr>    <chr>     <chr> 
1 Number of patients with event                        level    ..ard_hi… 69 (8…
2 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS level    AESOC     21 (2…
3 APPLICATION SITE PRURITUS                            level    AETERM    6 (7.…
4 APPLICATION SITE ERYTHEMA                            level    AETERM    3 (3.…
5 APPLICATION SITE DERMATITIS                          level    AETERM    5 (5.…
6 APPLICATION SITE IRRITATION                          level    AETERM    3 (3.…
7 APPLICATION SITE VESICLES                            level    AETERM    1 (1.…
8 FATIGUE                                              level    AETERM    1 (1.…

names(tbl$table_styling)

 [1] "header"                   "spanning_header"         
 [3] "footnote_header"          "footnote_body"           
 [5] "footnote_spanning_header" "abbreviation"            
 [7] "source_note"              "text_format"             
 [9] "indent"                   "fmt_missing"             
[11] "fmt_fun"                  "cols_merge"              
[13] "post_fmt_fun"

2. Parse

Rows, visible columns, labels, indent,
spanning headers, and format metadata.

tbl$table_styling$header |>
  dplyr::slice_head(n = 8)

# A tibble: 8 × 9
  column       hide  align interpret_label label modify_stat_level modify_stat_N
  <chr>        <lgl> <chr> <chr>           <chr> <chr>                     <int>
1 row_type     TRUE  cent… gt::md          "row… <NA>                        254
2 group1       TRUE  cent… gt::md          "gro… <NA>                        254
3 group1_level TRUE  cent… gt::md          "gro… <NA>                        254
4 var_label    TRUE  cent… gt::md          "var… <NA>                        254
5 variable     TRUE  cent… gt::md          "var… <NA>                        254
6 label        FALSE left  gt::md          "Sys… <NA>                        254
7 stat_1       FALSE cent… gt::md          "**P… Placebo                     254
8 stat_2       FALSE cent… gt::md          "**X… Xanomeline High …           254
# ℹ 2 more variables: modify_stat_n <int>, modify_stat_p <dbl>

3. Map (create_table + define)

Turn the parsed layout into column rules: widths, align, borders, footnotes.

library(reporter)

direct_tbl <- create_table(
  direct_df,
  first_row_blank = TRUE,
  header_bold = TRUE,
  borders = c("top", "bottom")
) |>
  define(
    label,
    label = header_map$label[header_map$column == "label"],
    width = 4.2,
    align = "left"
  ) |>
  define(
    stat_1,
    label = header_map$label[header_map$column == stat_cols[1]],
    width = 1.4,
    align = "center"
  ) |>
  define(
    stat_2,
    label = header_map$label[header_map$column == stat_cols[2]],
    width = 1.4,
    align = "center"
  ) |>
  footnotes(
    "Source: same gtsummary table_body, rendered directly with reporter.",
    blank_row = "none"
  )

4. Report object

Assemble titles, margins, and attach the table object.

direct_rpt <- create_report(
  font = "Courier",
  orientation = "landscape",
  font_size = 8
) |>
  titles(
    "Table 14.2 TEAE Summary by SOC and PT",
    bold = TRUE,
    align = "left"
  ) |>
  add_content(direct_tbl)

5. Output

Write TXT and RTF from the same report object.

direct_txt <- tempfile(fileext = ".txt")
direct_rtf <- tempfile(fileext = ".rtf")

write_report(direct_rpt, direct_txt, output_type = "TXT")

# A report specification: 8 pages
- file_path: 'C:\Users\KATHYZ~1\AppData\Local\Temp\RtmpmGHAGy\file11ec0375c6b16.txt'
- output_type: TXT
- units: inches
- orientation: landscape
- margins: top 0.5 bottom 0.5 left 1 right 1
- line size/count: 108/45
- title 1: 'Table 14.2 TEAE Summary by SOC and PT'
- content: 
# A table specification:
- data: tibble 'direct_df' 266 rows 3 cols
- show_cols: all
- use_attributes: all
- footnote 1: 'Source: same gtsummary table_body, rendered directly with reporter.'
- define: label 'System Organ Class / Preferred Term' width=4.2 align='left' 
- define: stat_1 '**Placebo**  
N = 86' width=1.4 align='center' 
- define: stat_2 '**Xanomeline High Dose**  
N = 84' width=1.4 align='center'

write_report(direct_rpt, direct_rtf, output_type = "RTF")

# A report specification: 7 pages
- file_path: 'C:\Users\KATHYZ~1\AppData\Local\Temp\RtmpmGHAGy\file11ec07bc46a58.rtf'
- output_type: RTF
- units: inches
- orientation: landscape
- margins: top 0.5 bottom 0.5 left 1 right 1
- line size/count: 9/46
- title 1: 'Table 14.2 TEAE Summary by SOC and PT'
- content: 
# A table specification:
- data: tibble 'direct_df' 266 rows 3 cols
- show_cols: all
- use_attributes: all
- footnote 1: 'Source: same gtsummary table_body, rendered directly with reporter.'
- define: label 'System Organ Class / Preferred Term' width=4.2 align='left' 
- define: stat_1 '**Placebo**  
N = 86' width=1.4 align='center' 
- define: stat_2 '**Xanomeline High Dose**  
N = 84' width=1.4 align='center'

RDS / output-like tables from gtsummary_to_reporter_clinical() are optional add-ons, not shown here.

6. TXT preview

Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

            Number of patients with event                         69 (80%)         79 (94%)
            GENERAL DISORDERS AND ADMINISTRATION SITE             21 (24%)         40 (48%)
            CONDITIONS
              APPLICATION SITE PRURITUS                           6 (7.0%)         22 (26%)
              APPLICATION SITE ERYTHEMA                           3 (3.5%)         15 (18%)
              APPLICATION SITE DERMATITIS                         5 (5.8%)         7 (8.3%)
              APPLICATION SITE IRRITATION                         3 (3.5%)         9 (11%)
              APPLICATION SITE VESICLES                           1 (1.2%)         6 (7.1%)
              FATIGUE                                             1 (1.2%)         5 (6.0%)
              OEDEMA PERIPHERAL                                   2 (2.3%)         2 (2.4%)
              APPLICATION SITE SWELLING                            0 (0%)          2 (2.4%)
              APPLICATION SITE URTICARIA                           0 (0%)          1 (1.2%)
              CHILLS                                              1 (1.2%)         1 (1.2%)
              MALAISE                                              0 (0%)          2 (2.4%)
              PYREXIA                                             2 (2.3%)         1 (1.2%)
              APPLICATION SITE PAIN                                0 (0%)          2 (2.4%)
              APPLICATION SITE PERSPIRATION                        0 (0%)          2 (2.4%)
              APPLICATION SITE REACTION                           1 (1.2%)         1 (1.2%)
              ASTHENIA                                            1 (1.2%)         1 (1.2%)
              CHEST DISCOMFORT                                     0 (0%)          2 (2.4%)
              CHEST PAIN                                           0 (0%)          2 (2.4%)
              OEDEMA                                               0 (0%)           0 (0%)
              PAIN                                                 0 (0%)          1 (1.2%)
              APPLICATION SITE BLEEDING                            0 (0%)           0 (0%)
              APPLICATION SITE DESQUAMATION                        0 (0%)           0 (0%)
              APPLICATION SITE DISCHARGE                           0 (0%)          1 (1.2%)
              APPLICATION SITE DISCOLOURATION                      0 (0%)           0 (0%)
              APPLICATION SITE INDURATION                         1 (1.2%)          0 (0%)
              APPLICATION SITE WARMTH                              0 (0%)           0 (0%)
              CYST                                                 0 (0%)           0 (0%)
              FEELING ABNORMAL                                     0 (0%)          1 (1.2%)
              FEELING COLD                                         0 (0%)          1 (1.2%)
              INFLAMMATION                                         0 (0%)           0 (0%)
              SECRETION DISCHARGE                                  0 (0%)           0 (0%)
              SUDDEN DEATH                                         0 (0%)           0 (0%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              SWELLING                                             0 (0%)           0 (0%)
              ULCER                                                0 (0%)           0 (0%)
            SKIN AND SUBCUTANEOUS TISSUE DISORDERS                21 (24%)         42 (50%)
              PRURITUS                                            8 (9.3%)         26 (31%)
              ERYTHEMA                                            9 (10%)          14 (17%)
              RASH                                                5 (5.8%)         11 (13%)
              HYPERHIDROSIS                                       2 (2.3%)         8 (9.5%)
              SKIN IRRITATION                                     3 (3.5%)         5 (6.0%)
              BLISTER                                              0 (0%)          1 (1.2%)
              RASH PRURITIC                                        0 (0%)          2 (2.4%)
              PRURITUS GENERALISED                                 0 (0%)          1 (1.2%)
              RASH ERYTHEMATOUS                                    0 (0%)           0 (0%)
              URTICARIA                                            0 (0%)          1 (1.2%)
              ACTINIC KERATOSIS                                    0 (0%)          1 (1.2%)
              ALOPECIA                                            1 (1.2%)          0 (0%)
              COLD SWEAT                                          1 (1.2%)          0 (0%)
              DERMATITIS ATOPIC                                   1 (1.2%)          0 (0%)
              DERMATITIS CONTACT                                   0 (0%)           0 (0%)
              DRUG ERUPTION                                       1 (1.2%)          0 (0%)
              RASH MACULO-PAPULAR                                  0 (0%)          1 (1.2%)
              RASH PAPULAR                                         0 (0%)          1 (1.2%)
              SKIN EXFOLIATION                                     0 (0%)           0 (0%)
              SKIN ODOUR ABNORMAL                                  0 (0%)          1 (1.2%)
              SKIN ULCER                                          1 (1.2%)          0 (0%)
            NERVOUS SYSTEM DISORDERS                              12 (14%)         27 (32%)
              DIZZINESS                                           2 (2.3%)         12 (14%)
              HEADACHE                                            7 (8.1%)         6 (7.1%)
              SYNCOPE                                              0 (0%)          3 (3.6%)
              SOMNOLENCE                                          2 (2.3%)         1 (1.2%)
              TRANSIENT ISCHAEMIC ATTACK                           0 (0%)          1 (1.2%)
              BURNING SENSATION                                    0 (0%)          2 (2.4%)
              LETHARGY                                             0 (0%)          1 (1.2%)
              AMNESIA                                              0 (0%)          1 (1.2%)
              BALANCE DISORDER                                     0 (0%)           0 (0%)
              COGNITIVE DISORDER                                   0 (0%)          1 (1.2%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              COMPLEX PARTIAL SEIZURES                             0 (0%)           0 (0%)
              COORDINATION ABNORMAL                                0 (0%)           0 (0%)
              HEMIANOPIA HOMONYMOUS                                0 (0%)           0 (0%)
              HYPERSOMNIA                                          0 (0%)          1 (1.2%)
              PARAESTHESIA                                         0 (0%)          1 (1.2%)
              PARAESTHESIA ORAL                                    0 (0%)           0 (0%)
              PARKINSON'S DISEASE                                 1 (1.2%)          0 (0%)
              PAROSMIA                                             0 (0%)          1 (1.2%)
              PARTIAL SEIZURES WITH SECONDARY GENERALISATION       0 (0%)          1 (1.2%)
              PSYCHOMOTOR HYPERACTIVITY                           1 (1.2%)          0 (0%)
              STUPOR                                               0 (0%)           0 (0%)
              SYNCOPE VASOVAGAL                                    0 (0%)          1 (1.2%)
            GASTROINTESTINAL DISORDERS                            17 (20%)         21 (25%)
              DIARRHOEA                                           9 (10%)          4 (4.8%)
              VOMITING                                            3 (3.5%)         7 (8.3%)
              NAUSEA                                              3 (3.5%)         6 (7.1%)
              ABDOMINAL PAIN                                      1 (1.2%)         1 (1.2%)
              SALIVARY HYPERSECRETION                              0 (0%)          4 (4.8%)
              DYSPEPSIA                                           1 (1.2%)         1 (1.2%)
              ABDOMINAL DISCOMFORT                                 0 (0%)          1 (1.2%)
              CONSTIPATION                                        1 (1.2%)          0 (0%)
              DYSPHAGIA                                            0 (0%)           0 (0%)
              FLATULENCE                                          1 (1.2%)          0 (0%)
              GASTROINTESTINAL HAEMORRHAGE                         0 (0%)          1 (1.2%)
              GASTROOESOPHAGEAL REFLUX DISEASE                    1 (1.2%)          0 (0%)
              GLOSSITIS                                           1 (1.2%)          0 (0%)
              HIATUS HERNIA                                       1 (1.2%)          0 (0%)
              RECTAL HAEMORRHAGE                                   0 (0%)           0 (0%)
              STOMACH DISCOMFORT                                   0 (0%)          1 (1.2%)
            CARDIAC DISORDERS                                     13 (15%)         18 (21%)
              SINUS BRADYCARDIA                                   2 (2.3%)         8 (9.5%)
              MYOCARDIAL INFARCTION                               4 (4.7%)         4 (4.8%)
              ATRIAL FIBRILLATION                                 1 (1.2%)         3 (3.6%)
              ATRIOVENTRICULAR BLOCK SECOND DEGREE                2 (2.3%)         3 (3.6%)
              SUPRAVENTRICULAR EXTRASYSTOLES                      1 (1.2%)         1 (1.2%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              VENTRICULAR EXTRASYSTOLES                            0 (0%)          1 (1.2%)
              ATRIAL FLUTTER                                       0 (0%)          1 (1.2%)
              ATRIOVENTRICULAR BLOCK FIRST DEGREE                 1 (1.2%)          0 (0%)
              BUNDLE BRANCH BLOCK RIGHT                           1 (1.2%)          0 (0%)
              PALPITATIONS                                         0 (0%)           0 (0%)
              ATRIAL HYPERTROPHY                                  1 (1.2%)          0 (0%)
              BRADYCARDIA                                         1 (1.2%)          0 (0%)
              BUNDLE BRANCH BLOCK LEFT                            1 (1.2%)          0 (0%)
              CARDIAC DISORDER                                     0 (0%)          1 (1.2%)
              CARDIAC FAILURE CONGESTIVE                          1 (1.2%)          0 (0%)
              SINUS ARRHYTHMIA                                    1 (1.2%)          0 (0%)
              SUPRAVENTRICULAR TACHYCARDIA                         0 (0%)           0 (0%)
              TACHYCARDIA                                         1 (1.2%)          0 (0%)
              VENTRICULAR HYPERTROPHY                             1 (1.2%)          0 (0%)
              WOLFF-PARKINSON-WHITE SYNDROME                       0 (0%)           0 (0%)
            INFECTIONS AND INFESTATIONS                           16 (19%)         13 (15%)
              NASOPHARYNGITIS                                     2 (2.3%)         6 (7.1%)
              UPPER RESPIRATORY TRACT INFECTION                   6 (7.0%)         3 (3.6%)
              INFLUENZA                                           1 (1.2%)         1 (1.2%)
              URINARY TRACT INFECTION                             2 (2.3%)         1 (1.2%)
              CYSTITIS                                            1 (1.2%)         1 (1.2%)
              EAR INFECTION                                       2 (2.3%)          0 (0%)
              LOCALISED INFECTION                                 1 (1.2%)          0 (0%)
              BRONCHITIS                                          1 (1.2%)          0 (0%)
              CELLULITIS                                           0 (0%)           0 (0%)
              CERVICITIS                                          1 (1.2%)          0 (0%)
              GASTROENTERITIS VIRAL                               1 (1.2%)          0 (0%)
              HORDEOLUM                                            0 (0%)          1 (1.2%)
              LOWER RESPIRATORY TRACT INFECTION                    0 (0%)          1 (1.2%)
              ONYCHOMYCOSIS                                        0 (0%)           0 (0%)
              PNEUMONIA                                            0 (0%)           0 (0%)
              RHINITIS                                             0 (0%)          1 (1.2%)
              VAGINAL MYCOSIS                                     1 (1.2%)          0 (0%)
              VIRAL INFECTION                                      0 (0%)           0 (0%)
            RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS       10 (12%)         10 (12%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              COUGH                                               3 (3.5%)         5 (6.0%)
              NASAL CONGESTION                                    3 (3.5%)         3 (3.6%)
              DYSPNOEA                                            1 (1.2%)         1 (1.2%)
              EPISTAXIS                                            0 (0%)          2 (2.4%)
              PHARYNGOLARYNGEAL PAIN                               0 (0%)          1 (1.2%)
              RHINORRHOEA                                          0 (0%)          1 (1.2%)
              ALLERGIC GRANULOMATOUS ANGIITIS                      0 (0%)          1 (1.2%)
              DYSPHONIA                                            0 (0%)           0 (0%)
              EMPHYSEMA                                           1 (1.2%)          0 (0%)
              HAEMOPTYSIS                                         1 (1.2%)          0 (0%)
              PHARYNGEAL ERYTHEMA                                  0 (0%)          1 (1.2%)
              POSTNASAL DRIP                                      1 (1.2%)          0 (0%)
              PRODUCTIVE COUGH                                     0 (0%)          1 (1.2%)
              RALES                                               1 (1.2%)          0 (0%)
              RESPIRATORY TRACT CONGESTION                         0 (0%)          1 (1.2%)
            PSYCHIATRIC DISORDERS                                 10 (12%)         9 (11%)
              CONFUSIONAL STATE                                   2 (2.3%)         1 (1.2%)
              AGITATION                                           2 (2.3%)         1 (1.2%)
              ANXIETY                                             1 (1.2%)          0 (0%)
              INSOMNIA                                            2 (2.3%)         2 (2.4%)
              DELUSION                                            1 (1.2%)         1 (1.2%)
              DEPRESSED MOOD                                       0 (0%)          1 (1.2%)
              IRRITABILITY                                        1 (1.2%)          0 (0%)
              COMPLETED SUICIDE                                   1 (1.2%)          0 (0%)
              DELIRIUM                                             0 (0%)          1 (1.2%)
              DISORIENTATION                                      1 (1.2%)          0 (0%)
              HALLUCINATION                                        0 (0%)          1 (1.2%)
              HALLUCINATION, VISUAL                                0 (0%)          1 (1.2%)
              LIBIDO DECREASED                                     0 (0%)          1 (1.2%)
              LISTLESS                                             0 (0%)          1 (1.2%)
              NIGHTMARE                                            0 (0%)          1 (1.2%)
              RESTLESSNESS                                         0 (0%)           0 (0%)
            INVESTIGATIONS                                        10 (12%)         6 (7.1%)
              ELECTROCARDIOGRAM ST SEGMENT DEPRESSION             4 (4.7%)          0 (0%)
              ELECTROCARDIOGRAM T WAVE INVERSION                  2 (2.3%)         1 (1.2%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              BLOOD GLUCOSE INCREASED                              0 (0%)          1 (1.2%)
              ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED        1 (1.2%)          0 (0%)
              BIOPSY                                               0 (0%)          1 (1.2%)
              BIOPSY PROSTATE                                      0 (0%)          1 (1.2%)
              BLOOD ALKALINE PHOSPHATASE INCREASED                1 (1.2%)          0 (0%)
              BLOOD CHOLESTEROL INCREASED                          0 (0%)          1 (1.2%)
              BLOOD CREATINE PHOSPHOKINASE INCREASED              1 (1.2%)          0 (0%)
              BLOOD URINE PRESENT                                 1 (1.2%)          0 (0%)
              BODY TEMPERATURE INCREASED                           0 (0%)           0 (0%)
              CYSTOSCOPY                                          1 (1.2%)          0 (0%)
              HEART RATE INCREASED                                1 (1.2%)          0 (0%)
              HEART RATE IRREGULAR                                1 (1.2%)          0 (0%)
              NASAL MUCOSA BIOPSY                                  0 (0%)           0 (0%)
              NEUTROPHIL COUNT INCREASED                           0 (0%)           0 (0%)
              URINE ANALYSIS ABNORMAL                              0 (0%)           0 (0%)
              WEIGHT DECREASED                                     0 (0%)          1 (1.2%)
              WHITE BLOOD CELL COUNT INCREASED                     0 (0%)           0 (0%)
            MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS       5 (5.8%)         8 (9.5%)
              BACK PAIN                                           1 (1.2%)         3 (3.6%)
              ARTHRALGIA                                          1 (1.2%)         1 (1.2%)
              SHOULDER PAIN                                       1 (1.2%)          0 (0%)
              ARTHRITIS                                           1 (1.2%)         1 (1.2%)
              FLANK PAIN                                           0 (0%)          2 (2.4%)
              MUSCLE SPASMS                                        0 (0%)          1 (1.2%)
              MUSCULAR WEAKNESS                                    0 (0%)           0 (0%)
              MYALGIA                                              0 (0%)          1 (1.2%)
              PAIN IN EXTREMITY                                   1 (1.2%)          0 (0%)
            INJURY, POISONING AND PROCEDURAL COMPLICATIONS        4 (4.7%)         5 (6.0%)
              CONTUSION                                           1 (1.2%)         2 (2.4%)
              EXCORIATION                                         2 (2.3%)         1 (1.2%)
              FALL                                                1 (1.2%)         1 (1.2%)
              HIP FRACTURE                                        1 (1.2%)         2 (2.4%)
              SKIN LACERATION                                     1 (1.2%)          0 (0%)
              FACIAL BONES FRACTURE                                0 (0%)          1 (1.2%)
              JOINT DISLOCATION                                    0 (0%)           0 (0%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              WOUND                                                0 (0%)           0 (0%)
            RENAL AND URINARY DISORDERS                           4 (4.7%)         3 (3.6%)
              MICTURITION URGENCY                                 1 (1.2%)         1 (1.2%)
              DYSURIA                                             1 (1.2%)          0 (0%)
              NEPHROLITHIASIS                                     1 (1.2%)         1 (1.2%)
              CALCULUS URETHRAL                                    0 (0%)          1 (1.2%)
              ENURESIS                                             0 (0%)           0 (0%)
              INCONTINENCE                                         0 (0%)           0 (0%)
              POLLAKIURIA                                         1 (1.2%)          0 (0%)
            METABOLISM AND NUTRITION DISORDERS                    6 (7.0%)         3 (3.6%)
              DECREASED APPETITE                                  1 (1.2%)         1 (1.2%)
              FOOD CRAVING                                        1 (1.2%)          0 (0%)
              INCREASED APPETITE                                  1 (1.2%)         1 (1.2%)
              DEHYDRATION                                         1 (1.2%)          0 (0%)
              DIABETES MELLITUS                                   1 (1.2%)          0 (0%)
              HYPERCHOLESTEROLAEMIA                                0 (0%)          1 (1.2%)
              HYPONATRAEMIA                                       1 (1.2%)          0 (0%)
            VASCULAR DISORDERS                                    3 (3.5%)         2 (2.4%)
              HYPERTENSION                                        1 (1.2%)         1 (1.2%)
              HYPOTENSION                                         2 (2.3%)          0 (0%)
              HOT FLUSH                                            0 (0%)           0 (0%)
              ORTHOSTATIC HYPOTENSION                             1 (1.2%)          0 (0%)
              WOUND HAEMORRHAGE                                    0 (0%)          1 (1.2%)
            EYE DISORDERS                                         4 (4.7%)         1 (1.2%)
              CONJUNCTIVITIS                                      2 (2.3%)          0 (0%)
              VISION BLURRED                                       0 (0%)          1 (1.2%)
              CONJUNCTIVAL HAEMORRHAGE                             0 (0%)           0 (0%)
              EYE ALLERGY                                         1 (1.2%)          0 (0%)
              EYE PRURITUS                                        1 (1.2%)          0 (0%)
              EYE SWELLING                                        1 (1.2%)          0 (0%)
              GLAUCOMA                                            1 (1.2%)          0 (0%)
            SURGICAL AND MEDICAL PROCEDURES                       2 (2.3%)         2 (2.4%)
              CATARACT OPERATION                                  1 (1.2%)          0 (0%)
              ACROCHORDON EXCISION                                 0 (0%)          1 (1.2%)
              EYE LASER SURGERY                                   1 (1.2%)          0 (0%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.
Table 14.2 TEAE Summary by SOC and PT

            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
                                                                                 **Xanomeline
                                                                **Placebo**      High Dose**
            System Organ Class / Preferred Term                    N = 86           N = 84
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

              SKIN LESION EXCISION                                 0 (0%)          1 (1.2%)
            EAR AND LABYRINTH DISORDERS                           1 (1.2%)         1 (1.2%)
              VERTIGO                                              0 (0%)          1 (1.2%)
              CERUMEN IMPACTION                                    0 (0%)           0 (0%)
              EAR PAIN                                            1 (1.2%)          0 (0%)
              TINNITUS                                             0 (0%)           0 (0%)
            CONGENITAL, FAMILIAL AND GENETIC DISORDERS             0 (0%)          2 (2.4%)
              VENTRICULAR SEPTAL DEFECT                            0 (0%)          2 (2.4%)
            NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL      0 (0%)          1 (1.2%)
            CYSTS AND POLYPS)
              COLON CANCER                                         0 (0%)           0 (0%)
              MALIGNANT FIBROUS HISTIOCYTOMA                       0 (0%)           0 (0%)
              PROSTATE CANCER                                      0 (0%)          1 (1.2%)
            REPRODUCTIVE SYSTEM AND BREAST DISORDERS              2 (2.3%)         1 (1.2%)
              BENIGN PROSTATIC HYPERPLASIA                        1 (1.2%)         1 (1.2%)
              PELVIC PAIN                                         1 (1.2%)          0 (0%)
            IMMUNE SYSTEM DISORDERS                                0 (0%)          1 (1.2%)
              HYPERSENSITIVITY                                     0 (0%)           0 (0%)
              SEASONAL ALLERGY                                     0 (0%)          1 (1.2%)
            HEPATOBILIARY DISORDERS                               1 (1.2%)          0 (0%)
              HYPERBILIRUBINAEMIA                                 1 (1.2%)          0 (0%)
            SOCIAL CIRCUMSTANCES                                   0 (0%)          1 (1.2%)
              ALCOHOL USE                                          0 (0%)          1 (1.2%)
            ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
            Source: same gtsummary table_body, rendered directly with reporter.

Why build an automation function?

Automation pipeline (gtsummary_to_reporter_clinical())

%%{init: {
  "flowchart": {
    "htmlLabels": true,
    "wrap": true,
    "padding": 22,
    "nodeSpacing": 62,
    "rankSpacing": 44
  },
  "theme": "dark",
  "themeVariables": {
    "fontSize": "15px",
    "fontFamily": "Arial, Helvetica, sans-serif"
  }
}}%%
flowchart TD
    A["gtsummary object"] --> B["Extract<br/>table_body + table_styling"]
    B --> C["Translate styling<br/>headers, indent, spanning, footnotes"]
    C --> D["Apply report rules<br/>pagination, widths, repeated stub, footer"]
    D --> E["Write final output<br/>TXT / RTF"]
    E --> F["Create ARD result dataset<br/>gtsummary::gather_ard() → _ard.rds"]

    style A fill:#0f4c5c,stroke:#8be9fd,stroke-width:3px,color:#ffffff
    style B fill:#355070,stroke:#8ecae6,stroke-width:3px,color:#ffffff
    style C fill:#5a189a,stroke:#d0a2ff,stroke-width:3px,color:#ffffff
    style D fill:#2d6a4f,stroke:#50fa7b,stroke-width:3px,color:#ffffff
    style E fill:#9d0208,stroke:#ff79c6,stroke-width:3px,color:#ffffff
    style F fill:#1e3a5f,stroke:#93c5fd,stroke-width:3px,color:#ffffff

1. Input

You can use reporter on a data.frame or table_body — but redoing formatting every table does not scale.

Start from a gtsummary object (here tbl from earlier).

2. Extract

Pull table_body and table_styling — the same pieces you would inspect by hand.

3. Translate styling

Map headers, stub indent, spanning headers, and footnotes into reporter column rules.

Also covered automatically: column labels, spanning, footnotes metadata.

4. Apply report rules

Pagination, column widths, repeated stub labels, page footer (e.g. from progname), and output-oriented data extraction.

5. Example — one call, several artifacts

One call produces the paginated TXT; with save_rds = TRUE it also writes _output_data.rds and _ard.rds.

source("gtsummary2rtf.r")

title1 <- "Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT"
footnote1 <- "Source: cards::ADAE example. TXT pagination and footer shown for illustration."
progname <- "ctr/t-ae-freq.r"

gts_txt <- tempfile(fileext = ".txt")

out_path <- gtsummary_to_reporter_clinical(
  gts_obj = tbl,
  file_path = gts_txt,
  output_types = "TXT",
  rows_per_page = 8,
  column_labels = c(label = "System Organ Class / Preferred Term"),
  column_widths = "22|12|12|12",
  label_repeat_on_page = TRUE,
  save_rds = TRUE
)

rds_output <- sub("\\.txt$", "_output_data.rds", gts_txt)
rds_ard <- sub("\\.txt$", "_ard.rds", gts_txt)

6. Write output

Produce final TXT / RTF with consistent trial-style layout.

TXT — paginated report

Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

Number of patients with event                69 (80%)               79 (94%)               77 (92%)

GENERAL DISORDERS AND ADMINISTRATION         21 (24%)               40 (48%)               47 (56%)
SITE CONDITIONS
    APPLICATION SITE PRURITUS                6 (7.0%)               22 (26%)               22 (26%)
    APPLICATION SITE ERYTHEMA                3 (3.5%)               15 (18%)               12 (14%)
    APPLICATION SITE DERMATITIS              5 (5.8%)               7 (8.3%)               9 (11%)
    APPLICATION SITE IRRITATION              3 (3.5%)               9 (11%)                9 (11%)
    APPLICATION SITE VESICLES                1 (1.2%)               6 (7.1%)               4 (4.8%)
    FATIGUE                                  1 (1.2%)               5 (6.0%)               5 (6.0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    OEDEMA PERIPHERAL                        2 (2.3%)               2 (2.4%)               1 (1.2%)
    APPLICATION SITE SWELLING                 0 (0%)                2 (2.4%)               1 (1.2%)
    APPLICATION SITE URTICARIA                0 (0%)                1 (1.2%)               2 (2.4%)
    CHILLS                                   1 (1.2%)               1 (1.2%)               1 (1.2%)
    MALAISE                                   0 (0%)                2 (2.4%)               1 (1.2%)
    PYREXIA                                  2 (2.3%)               1 (1.2%)                0 (0%)
    APPLICATION SITE PAIN                     0 (0%)                2 (2.4%)                0 (0%)
    APPLICATION SITE PERSPIRATION             0 (0%)                2 (2.4%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    APPLICATION SITE REACTION                1 (1.2%)               1 (1.2%)                0 (0%)
    ASTHENIA                                 1 (1.2%)               1 (1.2%)                0 (0%)
    CHEST DISCOMFORT                          0 (0%)                2 (2.4%)                0 (0%)
    CHEST PAIN                                0 (0%)                2 (2.4%)                0 (0%)
    OEDEMA                                    0 (0%)                 0 (0%)                2 (2.4%)
    PAIN                                      0 (0%)                1 (1.2%)               1 (1.2%)
    APPLICATION SITE BLEEDING                 0 (0%)                 0 (0%)                1 (1.2%)
    APPLICATION SITE DESQUAMATION             0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    APPLICATION SITE DISCHARGE                0 (0%)                1 (1.2%)                0 (0%)
    APPLICATION SITE DISCOLOURATION           0 (0%)                 0 (0%)                1 (1.2%)
    APPLICATION SITE INDURATION              1 (1.2%)                0 (0%)                 0 (0%)
    APPLICATION SITE WARMTH                   0 (0%)                 0 (0%)                1 (1.2%)
    CYST                                      0 (0%)                 0 (0%)                1 (1.2%)
    FEELING ABNORMAL                          0 (0%)                1 (1.2%)                0 (0%)
    FEELING COLD                              0 (0%)                1 (1.2%)                0 (0%)
    INFLAMMATION                              0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    SECRETION DISCHARGE                       0 (0%)                 0 (0%)                1 (1.2%)
    SUDDEN DEATH                              0 (0%)                 0 (0%)                1 (1.2%)
    SWELLING                                  0 (0%)                 0 (0%)                1 (1.2%)
    ULCER                                     0 (0%)                 0 (0%)                1 (1.2%)

SKIN AND SUBCUTANEOUS TISSUE                 21 (24%)               42 (50%)               42 (50%)
DISORDERS
    PRURITUS                                 8 (9.3%)               26 (31%)               23 (27%)
    ERYTHEMA                                 9 (10%)                14 (17%)               15 (18%)
    RASH                                     5 (5.8%)               11 (13%)               13 (15%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    HYPERHIDROSIS                            2 (2.3%)               8 (9.5%)               4 (4.8%)
    SKIN IRRITATION                          3 (3.5%)               5 (6.0%)               6 (7.1%)
    BLISTER                                   0 (0%)                1 (1.2%)               5 (6.0%)
    RASH PRURITIC                             0 (0%)                2 (2.4%)               1 (1.2%)
    PRURITUS GENERALISED                      0 (0%)                1 (1.2%)               1 (1.2%)
    RASH ERYTHEMATOUS                         0 (0%)                 0 (0%)                2 (2.4%)
    URTICARIA                                 0 (0%)                1 (1.2%)               1 (1.2%)
    ACTINIC KERATOSIS                         0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    ALOPECIA                                 1 (1.2%)                0 (0%)                 0 (0%)
    COLD SWEAT                               1 (1.2%)                0 (0%)                 0 (0%)
    DERMATITIS ATOPIC                        1 (1.2%)                0 (0%)                 0 (0%)
    DERMATITIS CONTACT                        0 (0%)                 0 (0%)                1 (1.2%)
    DRUG ERUPTION                            1 (1.2%)                0 (0%)                 0 (0%)
    RASH MACULO-PAPULAR                       0 (0%)                1 (1.2%)                0 (0%)
    RASH PAPULAR                              0 (0%)                1 (1.2%)                0 (0%)
    SKIN EXFOLIATION                          0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    SKIN ODOUR ABNORMAL                       0 (0%)                1 (1.2%)                0 (0%)
    SKIN ULCER                               1 (1.2%)                0 (0%)                 0 (0%)

NERVOUS SYSTEM DISORDERS                     12 (14%)               27 (32%)               20 (24%)
    DIZZINESS                                2 (2.3%)               12 (14%)               8 (9.5%)
    HEADACHE                                 7 (8.1%)               6 (7.1%)               3 (3.6%)
    SYNCOPE                                   0 (0%)                3 (3.6%)               4 (4.8%)
    SOMNOLENCE                               2 (2.3%)               1 (1.2%)               3 (3.6%)
    TRANSIENT ISCHAEMIC ATTACK                0 (0%)                1 (1.2%)               2 (2.4%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    BURNING SENSATION                         0 (0%)                2 (2.4%)                0 (0%)
    LETHARGY                                  0 (0%)                1 (1.2%)               1 (1.2%)
    AMNESIA                                   0 (0%)                1 (1.2%)                0 (0%)
    BALANCE DISORDER                          0 (0%)                 0 (0%)                1 (1.2%)
    COGNITIVE DISORDER                        0 (0%)                1 (1.2%)                0 (0%)
    COMPLEX PARTIAL SEIZURES                  0 (0%)                 0 (0%)                1 (1.2%)
    COORDINATION ABNORMAL                     0 (0%)                 0 (0%)                1 (1.2%)
    HEMIANOPIA HOMONYMOUS                     0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    HYPERSOMNIA                               0 (0%)                1 (1.2%)                0 (0%)
    PARAESTHESIA                              0 (0%)                1 (1.2%)                0 (0%)
    PARAESTHESIA ORAL                         0 (0%)                 0 (0%)                1 (1.2%)
    PARKINSON'S DISEASE                      1 (1.2%)                0 (0%)                 0 (0%)
    PAROSMIA                                  0 (0%)                1 (1.2%)                0 (0%)
    PARTIAL SEIZURES WITH SECONDARY           0 (0%)                1 (1.2%)                0 (0%)
GENERALISATION
    PSYCHOMOTOR HYPERACTIVITY                1 (1.2%)                0 (0%)                 0 (0%)
    STUPOR                                    0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    SYNCOPE VASOVAGAL                         0 (0%)                1 (1.2%)                0 (0%)

GASTROINTESTINAL DISORDERS                   17 (20%)               21 (25%)               15 (18%)
    DIARRHOEA                                9 (10%)                4 (4.8%)               5 (6.0%)
    VOMITING                                 3 (3.5%)               7 (8.3%)               3 (3.6%)
    NAUSEA                                   3 (3.5%)               6 (7.1%)               3 (3.6%)
    ABDOMINAL PAIN                           1 (1.2%)               1 (1.2%)               3 (3.6%)
    SALIVARY HYPERSECRETION                   0 (0%)                4 (4.8%)                0 (0%)
    DYSPEPSIA                                1 (1.2%)               1 (1.2%)               1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    ABDOMINAL DISCOMFORT                      0 (0%)                1 (1.2%)                0 (0%)
    CONSTIPATION                             1 (1.2%)                0 (0%)                 0 (0%)
    DYSPHAGIA                                 0 (0%)                 0 (0%)                1 (1.2%)
    FLATULENCE                               1 (1.2%)                0 (0%)                 0 (0%)
    GASTROINTESTINAL HAEMORRHAGE              0 (0%)                1 (1.2%)                0 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE         1 (1.2%)                0 (0%)                 0 (0%)
    GLOSSITIS                                1 (1.2%)                0 (0%)                 0 (0%)
    HIATUS HERNIA                            1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    RECTAL HAEMORRHAGE                        0 (0%)                 0 (0%)                1 (1.2%)
    STOMACH DISCOMFORT                        0 (0%)                1 (1.2%)                0 (0%)

CARDIAC DISORDERS                            13 (15%)               18 (21%)               13 (15%)
    SINUS BRADYCARDIA                        2 (2.3%)               8 (9.5%)               7 (8.3%)
    MYOCARDIAL INFARCTION                    4 (4.7%)               4 (4.8%)               2 (2.4%)
    ATRIAL FIBRILLATION                      1 (1.2%)               3 (3.6%)               1 (1.2%)
    ATRIOVENTRICULAR BLOCK SECOND            2 (2.3%)               3 (3.6%)                0 (0%)
DEGREE
    SUPRAVENTRICULAR EXTRASYSTOLES           1 (1.2%)               1 (1.2%)               1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    VENTRICULAR EXTRASYSTOLES                 0 (0%)                1 (1.2%)               2 (2.4%)
    ATRIAL FLUTTER                            0 (0%)                1 (1.2%)               1 (1.2%)
    ATRIOVENTRICULAR BLOCK FIRST             1 (1.2%)                0 (0%)                1 (1.2%)
DEGREE
    BUNDLE BRANCH BLOCK RIGHT                1 (1.2%)                0 (0%)                1 (1.2%)
    PALPITATIONS                              0 (0%)                 0 (0%)                2 (2.4%)
    ATRIAL HYPERTROPHY                       1 (1.2%)                0 (0%)                 0 (0%)
    BRADYCARDIA                              1 (1.2%)                0 (0%)                 0 (0%)
    BUNDLE BRANCH BLOCK LEFT                 1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    CARDIAC DISORDER                          0 (0%)                1 (1.2%)                0 (0%)
    CARDIAC FAILURE CONGESTIVE               1 (1.2%)                0 (0%)                 0 (0%)
    SINUS ARRHYTHMIA                         1 (1.2%)                0 (0%)                 0 (0%)
    SUPRAVENTRICULAR TACHYCARDIA              0 (0%)                 0 (0%)                1 (1.2%)
    TACHYCARDIA                              1 (1.2%)                0 (0%)                 0 (0%)
    VENTRICULAR HYPERTROPHY                  1 (1.2%)                0 (0%)                 0 (0%)
    WOLFF-PARKINSON-WHITE SYNDROME            0 (0%)                 0 (0%)                1 (1.2%)

INFECTIONS AND INFESTATIONS                  16 (19%)               13 (15%)               10 (12%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    NASOPHARYNGITIS                          2 (2.3%)               6 (7.1%)               4 (4.8%)
    UPPER RESPIRATORY TRACT INFECTION        6 (7.0%)               3 (3.6%)               1 (1.2%)
    INFLUENZA                                1 (1.2%)               1 (1.2%)               1 (1.2%)
    URINARY TRACT INFECTION                  2 (2.3%)               1 (1.2%)                0 (0%)
    CYSTITIS                                 1 (1.2%)               1 (1.2%)                0 (0%)
    EAR INFECTION                            2 (2.3%)                0 (0%)                 0 (0%)
    LOCALISED INFECTION                      1 (1.2%)                0 (0%)                1 (1.2%)
    BRONCHITIS                               1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    CELLULITIS                                0 (0%)                 0 (0%)                1 (1.2%)
    CERVICITIS                               1 (1.2%)                0 (0%)                 0 (0%)
    GASTROENTERITIS VIRAL                    1 (1.2%)                0 (0%)                 0 (0%)
    HORDEOLUM                                 0 (0%)                1 (1.2%)                0 (0%)
    LOWER RESPIRATORY TRACT INFECTION         0 (0%)                1 (1.2%)                0 (0%)
    ONYCHOMYCOSIS                             0 (0%)                 0 (0%)                1 (1.2%)
    PNEUMONIA                                 0 (0%)                 0 (0%)                1 (1.2%)
    RHINITIS                                  0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    VAGINAL MYCOSIS                          1 (1.2%)                0 (0%)                 0 (0%)
    VIRAL INFECTION                           0 (0%)                 0 (0%)                1 (1.2%)

RESPIRATORY, THORACIC AND MEDIASTINAL        10 (12%)               10 (12%)               10 (12%)
DISORDERS
    COUGH                                    3 (3.5%)               5 (6.0%)               6 (7.1%)
    NASAL CONGESTION                         3 (3.5%)               3 (3.6%)               1 (1.2%)
    DYSPNOEA                                 1 (1.2%)               1 (1.2%)               1 (1.2%)
    EPISTAXIS                                 0 (0%)                2 (2.4%)               1 (1.2%)
    PHARYNGOLARYNGEAL PAIN                    0 (0%)                1 (1.2%)               1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    RHINORRHOEA                               0 (0%)                1 (1.2%)               1 (1.2%)
    ALLERGIC GRANULOMATOUS ANGIITIS           0 (0%)                1 (1.2%)                0 (0%)
    DYSPHONIA                                 0 (0%)                 0 (0%)                1 (1.2%)
    EMPHYSEMA                                1 (1.2%)                0 (0%)                 0 (0%)
    HAEMOPTYSIS                              1 (1.2%)                0 (0%)                 0 (0%)
    PHARYNGEAL ERYTHEMA                       0 (0%)                1 (1.2%)                0 (0%)
    POSTNASAL DRIP                           1 (1.2%)                0 (0%)                 0 (0%)
    PRODUCTIVE COUGH                          0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    RALES                                    1 (1.2%)                0 (0%)                 0 (0%)
    RESPIRATORY TRACT CONGESTION              0 (0%)                1 (1.2%)                0 (0%)

PSYCHIATRIC DISORDERS                        10 (12%)               9 (11%)                10 (12%)
    CONFUSIONAL STATE                        2 (2.3%)               1 (1.2%)               3 (3.6%)
    AGITATION                                2 (2.3%)               1 (1.2%)               2 (2.4%)
    ANXIETY                                  1 (1.2%)                0 (0%)                3 (3.6%)
    INSOMNIA                                 2 (2.3%)               2 (2.4%)                0 (0%)
    DELUSION                                 1 (1.2%)               1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    DEPRESSED MOOD                            0 (0%)                1 (1.2%)               1 (1.2%)
    IRRITABILITY                             1 (1.2%)                0 (0%)                1 (1.2%)
    COMPLETED SUICIDE                        1 (1.2%)                0 (0%)                 0 (0%)
    DELIRIUM                                  0 (0%)                1 (1.2%)                0 (0%)
    DISORIENTATION                           1 (1.2%)                0 (0%)                 0 (0%)
    HALLUCINATION                             0 (0%)                1 (1.2%)                0 (0%)
    HALLUCINATION, VISUAL                     0 (0%)                1 (1.2%)                0 (0%)
    LIBIDO DECREASED                          0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    LISTLESS                                  0 (0%)                1 (1.2%)                0 (0%)
    NIGHTMARE                                 0 (0%)                1 (1.2%)                0 (0%)
    RESTLESSNESS                              0 (0%)                 0 (0%)                1 (1.2%)

INVESTIGATIONS                               10 (12%)               6 (7.1%)               7 (8.3%)
    ELECTROCARDIOGRAM ST SEGMENT             4 (4.7%)                0 (0%)                1 (1.2%)
DEPRESSION
    ELECTROCARDIOGRAM T WAVE                 2 (2.3%)               1 (1.2%)               1 (1.2%)
INVERSION
    BLOOD GLUCOSE INCREASED                   0 (0%)                1 (1.2%)               1 (1.2%)
    ELECTROCARDIOGRAM T WAVE                 1 (1.2%)                0 (0%)                1 (1.2%)
AMPLITUDE DECREASED

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    BIOPSY                                    0 (0%)                1 (1.2%)                0 (0%)
    BIOPSY PROSTATE                           0 (0%)                1 (1.2%)                0 (0%)
    BLOOD ALKALINE PHOSPHATASE               1 (1.2%)                0 (0%)                 0 (0%)
INCREASED
    BLOOD CHOLESTEROL INCREASED               0 (0%)                1 (1.2%)                0 (0%)
    BLOOD CREATINE PHOSPHOKINASE             1 (1.2%)                0 (0%)                 0 (0%)
INCREASED
    BLOOD URINE PRESENT                      1 (1.2%)                0 (0%)                 0 (0%)
    BODY TEMPERATURE INCREASED                0 (0%)                 0 (0%)                1 (1.2%)
    CYSTOSCOPY                               1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    HEART RATE INCREASED                     1 (1.2%)                0 (0%)                 0 (0%)
    HEART RATE IRREGULAR                     1 (1.2%)                0 (0%)                 0 (0%)
    NASAL MUCOSA BIOPSY                       0 (0%)                 0 (0%)                1 (1.2%)
    NEUTROPHIL COUNT INCREASED                0 (0%)                 0 (0%)                1 (1.2%)
    URINE ANALYSIS ABNORMAL                   0 (0%)                 0 (0%)                1 (1.2%)
    WEIGHT DECREASED                          0 (0%)                1 (1.2%)                0 (0%)
    WHITE BLOOD CELL COUNT INCREASED          0 (0%)                 0 (0%)                1 (1.2%)

MUSCULOSKELETAL AND CONNECTIVE TISSUE        5 (5.8%)               8 (9.5%)               7 (8.3%)
DISORDERS

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    BACK PAIN                                1 (1.2%)               3 (3.6%)               1 (1.2%)
    ARTHRALGIA                               1 (1.2%)               1 (1.2%)               2 (2.4%)
    SHOULDER PAIN                            1 (1.2%)                0 (0%)                2 (2.4%)
    ARTHRITIS                                1 (1.2%)               1 (1.2%)                0 (0%)
    FLANK PAIN                                0 (0%)                2 (2.4%)                0 (0%)
    MUSCLE SPASMS                             0 (0%)                1 (1.2%)               1 (1.2%)
    MUSCULAR WEAKNESS                         0 (0%)                 0 (0%)                1 (1.2%)
    MYALGIA                                   0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    PAIN IN EXTREMITY                        1 (1.2%)                0 (0%)                 0 (0%)

INJURY, POISONING AND PROCEDURAL             4 (4.7%)               5 (6.0%)               5 (6.0%)
COMPLICATIONS
    CONTUSION                                1 (1.2%)               2 (2.4%)               1 (1.2%)
    EXCORIATION                              2 (2.3%)               1 (1.2%)               1 (1.2%)
    FALL                                     1 (1.2%)               1 (1.2%)               2 (2.4%)
    HIP FRACTURE                             1 (1.2%)               2 (2.4%)                0 (0%)
    SKIN LACERATION                          1 (1.2%)                0 (0%)                2 (2.4%)
    FACIAL BONES FRACTURE                     0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    JOINT DISLOCATION                         0 (0%)                 0 (0%)                1 (1.2%)
    WOUND                                     0 (0%)                 0 (0%)                1 (1.2%)

RENAL AND URINARY DISORDERS                  4 (4.7%)               3 (3.6%)               4 (4.8%)
    MICTURITION URGENCY                      1 (1.2%)               1 (1.2%)               1 (1.2%)
    DYSURIA                                  1 (1.2%)                0 (0%)                1 (1.2%)
    NEPHROLITHIASIS                          1 (1.2%)               1 (1.2%)                0 (0%)
    CALCULUS URETHRAL                         0 (0%)                1 (1.2%)                0 (0%)
    ENURESIS                                  0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    INCONTINENCE                              0 (0%)                 0 (0%)                1 (1.2%)
    POLLAKIURIA                              1 (1.2%)                0 (0%)                 0 (0%)

METABOLISM AND NUTRITION DISORDERS           6 (7.0%)               3 (3.6%)               1 (1.2%)
    DECREASED APPETITE                       1 (1.2%)               1 (1.2%)                0 (0%)
    FOOD CRAVING                             1 (1.2%)                0 (0%)                1 (1.2%)
    INCREASED APPETITE                       1 (1.2%)               1 (1.2%)                0 (0%)
    DEHYDRATION                              1 (1.2%)                0 (0%)                 0 (0%)
    DIABETES MELLITUS                        1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    HYPERCHOLESTEROLAEMIA                     0 (0%)                1 (1.2%)                0 (0%)
    HYPONATRAEMIA                            1 (1.2%)                0 (0%)                 0 (0%)

VASCULAR DISORDERS                           3 (3.5%)               2 (2.4%)               3 (3.6%)
    HYPERTENSION                             1 (1.2%)               1 (1.2%)               1 (1.2%)
    HYPOTENSION                              2 (2.3%)                0 (0%)                1 (1.2%)
    HOT FLUSH                                 0 (0%)                 0 (0%)                1 (1.2%)
    ORTHOSTATIC HYPOTENSION                  1 (1.2%)                0 (0%)                 0 (0%)
    WOUND HAEMORRHAGE                         0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

EYE DISORDERS                                4 (4.7%)               1 (1.2%)               2 (2.4%)
    CONJUNCTIVITIS                           2 (2.3%)                0 (0%)                 0 (0%)
    VISION BLURRED                            0 (0%)                1 (1.2%)               1 (1.2%)
    CONJUNCTIVAL HAEMORRHAGE                  0 (0%)                 0 (0%)                1 (1.2%)
    EYE ALLERGY                              1 (1.2%)                0 (0%)                 0 (0%)
    EYE PRURITUS                             1 (1.2%)                0 (0%)                 0 (0%)
    EYE SWELLING                             1 (1.2%)                0 (0%)                 0 (0%)
    GLAUCOMA                                 1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

SURGICAL AND MEDICAL PROCEDURES              2 (2.3%)               2 (2.4%)               1 (1.2%)
    CATARACT OPERATION                       1 (1.2%)                0 (0%)                1 (1.2%)
    ACROCHORDON EXCISION                      0 (0%)                1 (1.2%)                0 (0%)
    EYE LASER SURGERY                        1 (1.2%)                0 (0%)                 0 (0%)
    SKIN LESION EXCISION                      0 (0%)                1 (1.2%)                0 (0%)

EAR AND LABYRINTH DISORDERS                  1 (1.2%)               1 (1.2%)               2 (2.4%)
    VERTIGO                                   0 (0%)                1 (1.2%)               1 (1.2%)
    CERUMEN IMPACTION                         0 (0%)                 0 (0%)                1 (1.2%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

    EAR PAIN                                 1 (1.2%)                0 (0%)                 0 (0%)
    TINNITUS                                  0 (0%)                 0 (0%)                1 (1.2%)

CONGENITAL, FAMILIAL AND GENETIC              0 (0%)                2 (2.4%)               1 (1.2%)
DISORDERS
    VENTRICULAR SEPTAL DEFECT                 0 (0%)                2 (2.4%)               1 (1.2%)

NEOPLASMS BENIGN, MALIGNANT AND               0 (0%)                1 (1.2%)               2 (2.4%)
UNSPECIFIED (INCL CYSTS AND POLYPS)
    COLON CANCER                              0 (0%)                 0 (0%)                1 (1.2%)
    MALIGNANT FIBROUS HISTIOCYTOMA            0 (0%)                 0 (0%)                1 (1.2%)
    PROSTATE CANCER                           0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

REPRODUCTIVE SYSTEM AND BREAST               2 (2.3%)               1 (1.2%)                0 (0%)
DISORDERS
    BENIGN PROSTATIC HYPERPLASIA             1 (1.2%)               1 (1.2%)                0 (0%)
    PELVIC PAIN                              1 (1.2%)                0 (0%)                 0 (0%)

IMMUNE SYSTEM DISORDERS                       0 (0%)                1 (1.2%)               1 (1.2%)
    HYPERSENSITIVITY                          0 (0%)                 0 (0%)                1 (1.2%)
    SEASONAL ALLERGY                          0 (0%)                1 (1.2%)                0 (0%)

HEPATOBILIARY DISORDERS                      1 (1.2%)                0 (0%)                 0 (0%)
    HYPERBILIRUBINAEMIA                      1 (1.2%)                0 (0%)                 0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09
Table 14.2 Summary of Treatment-Emergent Adverse Events by SOC and PT

__________________________________________________________________________________________________________
                                             Placebo         Xanomeline High Dose    Xanomeline Low Dose
System Organ Class / Preferred Term           N = 86                 N = 84                 N = 84
__________________________________________________________________________________________________________

SOCIAL CIRCUMSTANCES                          0 (0%)                1 (1.2%)                0 (0%)
    ALCOHOL USE                               0 (0%)                1 (1.2%)                0 (0%)

__________________________________________________________________________________________________________
Source: cards::ADAE example. TXT pagination and footer shown for illustration.

                                                                             ctr/t-ae-freq.r 24MAR2026 23:09

7. RDS: output data + ARD

With save_rds = TRUE, _output_data.rds and _ard.rds are written next to the report file; for gtsummary objects the ARD is built with gtsummary::gather_ard().

`_output_data.rds`

# A tibble: 15 × 5
   label                                       stat_1 stat_2 stat_3 group1_level
   <chr>                                       <chr>  <chr>  <chr>  <chr>       
 1 "Number of patients with event"             69 (8… 79 (9… 77 (9… <NA>        
 2 "GENERAL DISORDERS AND ADMINISTRATION SITE… 21 (2… 40 (4… 47 (5… GENERAL DIS…
 3 "    APPLICATION SITE PRURITUS"             6 (7.… 22 (2… 22 (2… GENERAL DIS…
 4 "    APPLICATION SITE ERYTHEMA"             3 (3.… 15 (1… 12 (1… GENERAL DIS…
 5 "    APPLICATION SITE DERMATITIS"           5 (5.… 7 (8.… 9 (11… GENERAL DIS…
 6 "    APPLICATION SITE IRRITATION"           3 (3.… 9 (11… 9 (11… GENERAL DIS…
 7 "    APPLICATION SITE VESICLES"             1 (1.… 6 (7.… 4 (4.… GENERAL DIS…
 8 "    FATIGUE"                               1 (1.… 5 (6.… 5 (6.… GENERAL DIS…
 9 "    OEDEMA PERIPHERAL"                     2 (2.… 2 (2.… 1 (1.… GENERAL DIS…
10 "    APPLICATION SITE SWELLING"             0 (0%) 2 (2.… 1 (1.… GENERAL DIS…
11 "    APPLICATION SITE URTICARIA"            0 (0%) 1 (1.… 2 (2.… GENERAL DIS…
12 "    CHILLS"                                1 (1.… 1 (1.… 1 (1.… GENERAL DIS…
13 "    MALAISE"                               0 (0%) 2 (2.… 1 (1.… GENERAL DIS…
14 "    PYREXIA"                               2 (2.… 1 (1.… 0 (0%) GENERAL DIS…
15 "    APPLICATION SITE PAIN"                 0 (0%) 2 (2.… 0 (0%) GENERAL DIS…

`_ard.rds`

   group1 group1_level group2 group2_level                     variable
1    <NA>                <NA>                                      TRTA
2    <NA>                <NA>                                      TRTA
3    <NA>                <NA>                                      TRTA
4    <NA>                <NA>                                      TRTA
5    <NA>                <NA>                                      TRTA
6    <NA>                <NA>                                      TRTA
7    <NA>                <NA>                                      TRTA
8    <NA>                <NA>                                      TRTA
9    <NA>                <NA>                                      TRTA
10   TRTA      Placebo   <NA>              ..ard_hierarchical_overall..
   variable_level stat_name stat_label  stat stat_fmt
1         Placebo         n          n    86       86
2         Placebo         N          N   254      254
3         Placebo         p          % 0.339     33.9
4       Xanomeli…         n          n    84       84
5       Xanomeli…         N          N   254      254
6       Xanomeli…         p          % 0.331     33.1
7       Xanomeli…         n          n    84       84
8       Xanomeli…         N          N   254      254
9       Xanomeli…         p          % 0.331     33.1
10           TRUE         n          n    69       69

Automation layer: R vs SAS

Report engine

PROC REPORT

reporter

Automation — fewer parameters, fewer steps

%x_tlf_macro

gtsummary_to_reporter_clinical()

Better Together

%%{init: {
  "flowchart": {
    "htmlLabels": true,
    "wrap": true,
    "padding": 24,
    "nodeSpacing": 72,
    "rankSpacing": 72
  },
  "theme": "dark",
  "themeVariables": {
    "fontSize": "12px",
    "fontFamily": "Arial, Helvetica, sans-serif"
  }
}}%%
flowchart LR
    G["gtsummary / crane / cardinal<br/>content, statistics, ARD"] --> X["Build-on function<br/>gtsummary_to_reporter_clinical()"]
    R["reporter<br/>layout, formatting, pagination"] --> X
    X --> O1["1. Output<br/>e.g. TXT / RTF"]
    X --> O2["2. Result dataset"]
    X --> O3["3. Analysis result dataset"]

    style G fill:#0f4c5c,stroke:#8be9fd,stroke-width:3px,color:#ffffff
    style R fill:#5a189a,stroke:#d0a2ff,stroke-width:3px,color:#ffffff
    style X fill:#2d6a4f,stroke:#50fa7b,stroke-width:3px,color:#ffffff
    style O1 fill:#9d0208,stroke:#ff79c6,stroke-width:3px,color:#ffffff
    style O2 fill:#5c4d7d,stroke:#bd93f9,stroke-width:3px,color:#ffffff
    style O3 fill:#0d5c4a,stroke:#50fa7b,stroke-width:3px,color:#ffffff

Build-on function can work not only for standard gtsummary objects, but also for more complex stacked/list-like gtsummary objects
It translates gtsummary styling into reporter output while keeping pagination and footer handling
One run can yield report files, a result-style dataset, and an analysis-result dataset for QC and reuse

Summary

We can solve clinical-reporting problems more efficiently when we combine the strengths of multiple open-source tools, rather than expecting a single package to do everything.

In CTR in R, ARD can help us generate the outputs we want with more flexibility, but it is not the only option and it is not always the most efficient option for every table.
ARD should not be viewed only as a hidden intermediate object; in the future, it may itself become one of the key structured outputs produced by programmers.
AI is especially powerful when it builds on top of relatively mature packages to help generate output template code and reusable functions.

References & Resources

gtsummary: https://www.danieldsjoberg.com/gtsummary/
crane: https://github.com/insightsengineering/crane
reporter: https://reporter.r-sassy.org/
cards: https://insightsengineering.github.io/cards/
Cardinal (pharmaverse): FDA Table 15, etc.

Questions?

Thank you.