Configure pagination

Attach a pagination_spec to a tabular_spec. The engine uses the spec at render time to decide where page breaks fall, how wide tables split into horizontal panels, and what continuation marker (if any) prints on continued pages. The row budget per page is computed by the engine from the active preset (paper, orientation, margins, font size) and the chrome rows consumed by titles, column headers, and footnotes — you do not set rows-per-page directly.

Usage

paginate(
  .spec,
  keep_together = character(),
  panels = 1,
  orphan_floor = 3,
  widow_floor = 2,
  repeat_content = c("titles", "headers", "footnotes"),
  continuation = NULL
)

Arguments

.spec

The tabular_spec to attach pagination to. <tabular_spec>: required.

keep_together

Group columns whose runs of identical values must not be split across a page break. <character>: default character(). Every entry must be a usage = "group" column declared in cols().

Interaction: A run too tall to fit in the computed row budget less orphan_floor is split anyway; pagination is best-effort, not a hard contract.

# Protect the SOC-level grouping in an AE-by-SOC/PT table.
paginate(keep_together = "soc")

panels

Number of horizontal panels for wide tables. <integer(1)>: default 1. With 1, every column is on every page (single vertical scroll). With N > 1, the engine splits non-group columns into N chunks and repeats every group column on every panel.

orphan_floor

Minimum rows on a continued-from page. <integer(1)>: default 3. When keep_together would move a page break back so far that fewer than orphan_floor rows would ride on the current page, the engine splits the protected run anyway. Acts as the escape valve for groups too tall to fit.

widow_floor

Minimum rows on the final page. <integer(1)>: default 2. If the last page would carry fewer than widow_floor rows, the engine merges those rows back onto the previous page (page overflow accepted). Avoids the "one-row-orphaned-on-page-N" look without complicating the primary split rule.

repeat_content

Which page chrome repeats on every page. <character>: default c("titles", "headers", "footnotes"). A subset of those three values; each is governed independently:

"titles" — title block on every page (else page 1 only).
"headers" — column-header band on every page (else page 1 only).
"footnotes" — footnote block on every page (else last page only).

The default repeats all three so each page is self-contained per the submission layout contract. Pass a subset to drop one (e.g. c("headers", "footnotes") keeps the title on page 1 only), or character() to repeat nothing.

Note: Footnotes are always anchored to the page foot when present; membership only chooses every-page vs last-page-only, never table-body placement.

HTML / MD: ignored. HTML renders one continuous <table> and browsers natively repeat <thead> on print; MD has no print model. Effective only for the page-oriented backends (RTF, PDF, LaTeX, DOCX).

continuation

Marker text appended after a continuing table's title block. <character(1) | NULL>: default NULL. NULL (the default) renders no marker — pick the wording your submission style guide expects (e.g. "(continued)", "(Cont'd)", "Page %d of %d") and pass it explicitly.

Backend support is uneven — verify against your render target:

PDF / LaTeX — full: the marker prints on every continuation page (both vertical page overflow and horizontal panels).
RTF — horizontal continuation panels only (paginate(panels = N)); the marker does NOT appear on vertical page-overflow continuations.
DOCX — not marked. DOCX paginates natively but emits no continuation marker.
HTML / MD — ignored. With one continuous document on screen there is no continuing-page boundary to mark.

Value

The updated tabular_spec. Continue chaining with style(), preset(), then render via emit() (or resolve without I/O via as_grid()).

Details

Replace, not stack. A second paginate() call REPLACES the prior spec — pagination is a single configuration block, not a stackable list. Call with all defaults to clear back to the engine's auto behaviour.

Rows per page are computed, not configured. The engine takes the paper height for the active orientation (letter, a4) and subtracts the top + bottom margins, the title block height (number of title lines + a blank separator), the column-header band height (max embedded \n line count across visible column labels, plus any spanning header levels), and the footnote block height (number of footnote lines + a blank separator). The remainder, divided by the row height for the active font size, gives the body-row budget per page. Landscape pages naturally carry fewer rows than portrait at the same paper size; smaller fonts carry more.

keep_together protects group runs. When a page break would fall in the middle of a contiguous run of identical values in a usage = "group" column listed in keep_together, the engine moves the break BACK to the start of the run so the whole run rides on the next page. Single rule of escape: if moving the break back would leave fewer than orphan_floor rows on the current page, the engine splits the run anyway (a single group too tall to fit on one page cannot be kept together).

panels and group stickiness. With panels > 1, the engine splits the NON-group columns into approximately equal slices and repeats every usage = "group" column on every panel for row context.

Examples

# ---- Example 1: AE table paginated by SOC ----
#
# AE-by-SOC/PT table that may run several pages. The SOC column is
# protected by `keep_together` so a page break never lands in the
# middle of one SOC's PT rows. The engine derives the row budget
# from the preset's orientation + font_size + paper size and from
# the title / footnote / header line counts on the spec — no
# manual rows-per-page knob to keep in sync.
n <- stats::setNames(cdisc_saf_n$n, cdisc_saf_n$arm_short)

tabular(
  cdisc_saf_aesocpt,
  titles = c(
    "Table 14.3.1",
    "Adverse Events by System Organ Class and Preferred Term",
    "Safety Population"
  ),
  footnotes = "Subjects are counted once per SOC and once per PT."
) |>
  cols(
    label    = col_spec(label = "SOC / PT", indent = "indent_level"),
    soc      = col_spec(usage = "group", visible = FALSE,
                        group_display = "column_repeat"),
    row_type = col_spec(visible = FALSE),
    soc_n    = col_spec(visible = FALSE),
    n_total  = col_spec(visible = FALSE),
    placebo  = col_spec(label = "Placebo\nN={n['placebo']}"),
    drug_50  = col_spec(label = "Drug 50\nN={n['drug_50']}"),
    drug_100 = col_spec(label = "Drug 100\nN={n['drug_100']}"),
    Total    = col_spec(label = "Total\nN={n['Total']}")
  ) |>
  headers("Treatment Group" = c("placebo", "drug_50", "drug_100", "Total")) |>
  sort_rows(by = c("soc_n", "n_total"), descending = c(TRUE, TRUE)) |>
  paginate(
    keep_together = "soc",
    repeat_content = c("titles", "headers", "footnotes"),
    continuation = "(continued)"
  )
 
Table 14.3.1
Adverse Events by System Organ Class and Preferred Term
Safety Population
 

Treatment Group
SOC / PT Placebo
N=86 Drug 50
N=96 Drug 100
N=72 Total
N=254
TOTAL SUBJECTS WITH AN EVENT 52 (60.5) 81 (84.4) 66 (91.7) 199 (78.3)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 19 (22.1) 36 (37.5) 35 (48.6) 90 (35.4)
PRURITUS 8 (9.3) 21 (21.9) 25 (34.7) 54 (21.3)
ERYTHEMA 8 (9.3) 14 (14.6) 14 (19.4) 36 (14.2)
RASH 5 (5.8) 13 (13.5) 8 (11.1) 26 (10.2)
HYPERHIDROSIS 2 (2.3) 4 (4.2) 8 (11.1) 14 (5.5)
SKIN IRRITATION 3 (3.5) 6 (6.2) 5 (6.9) 14 (5.5)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 15 (17.4) 36 (37.5) 30 (41.7) 81 (31.9)
APPLICATION SITE PRURITUS 6 (7.0) 23 (24.0) 21 (29.2) 50 (19.7)
APPLICATION SITE ERYTHEMA 3 (3.5) 13 (13.5) 14 (19.4) 30 (11.8)
APPLICATION SITE DERMATITIS 5 (5.8) 9 (9.4) 7 (9.7) 21 (8.3)
APPLICATION SITE IRRITATION 3 (3.5) 9 (9.4) 9 (12.5) 21 (8.3)
APPLICATION SITE VESICLES 1 (1.2) 5 (5.2) 5 (6.9) 11 (4.3)
GASTROINTESTINAL DISORDERS 13 (15.1) 12 (12.5) 17 (23.6) 42 (16.5)
DIARRHOEA 9 (10.5) 5 (5.2) 3 (4.2) 17 (6.7)
VOMITING 3 (3.5) 4 (4.2) 6 (8.3) 13 (5.1)
NAUSEA 3 (3.5) 3 (3.1) 6 (8.3) 12 (4.7)
ABDOMINAL PAIN 1 (1.2) 3 (3.1) 1 (1.4) 5 (2.0)
SALIVARY HYPERSECRETION 0 (0.0) 0 (0.0) 4 (5.6) 4 (1.6)
NERVOUS SYSTEM DISORDERS 6 (7.0) 18 (18.8) 17 (23.6) 41 (16.1)
DIZZINESS 2 (2.3) 9 (9.4) 10 (13.9) 21 (8.3)
HEADACHE 3 (3.5) 3 (3.1) 5 (6.9) 11 (4.3)
SYNCOPE 0 (0.0) 5 (5.2) 2 (2.8) 7 (2.8)
SOMNOLENCE 2 (2.3) 3 (3.1) 1 (1.4) 6 (2.4)
TRANSIENT ISCHAEMIC ATTACK 0 (0.0) 2 (2.1) 1 (1.4) 3 (1.2)
CARDIAC DISORDERS 7 (8.1) 12 (12.5) 14 (19.4) 33 (13.0)
SINUS BRADYCARDIA 2 (2.3) 7 (7.3) 8 (11.1) 17 (6.7)
MYOCARDIAL INFARCTION 4 (4.7) 2 (2.1) 4 (5.6) 10 (3.9)
ATRIAL FIBRILLATION 1 (1.2) 2 (2.1) 2 (2.8) 5 (2.0)
SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2) 1 (1.0) 1 (1.4) 3 (1.2)
VENTRICULAR EXTRASYSTOLES 0 (0.0) 2 (2.1) 1 (1.4) 3 (1.2)
INFECTIONS AND INFESTATIONS 12 (14.0) 6 (6.2) 11 (15.3) 29 (11.4)
NASOPHARYNGITIS 2 (2.3) 4 (4.2) 6 (8.3) 12 (4.7)
UPPER RESPIRATORY TRACT INFECTION 6 (7.0) 1 (1.0) 3 (4.2) 10 (3.9)
INFLUENZA 1 (1.2) 1 (1.0) 1 (1.4) 3 (1.2)
URINARY TRACT INFECTION 2 (2.3) 0 (0.0) 1 (1.4) 3 (1.2)
CYSTITIS 1 (1.2) 0 (0.0) 1 (1.4) 2 (0.8)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 5 (5.8) 8 (8.3) 9 (12.5) 22 (8.7)
COUGH 1 (1.2) 5 (5.2) 5 (6.9) 11 (4.3)
NASAL CONGESTION 3 (3.5) 1 (1.0) 3 (4.2) 7 (2.8)
DYSPNOEA 1 (1.2) 1 (1.0) 1 (1.4) 3 (1.2)
EPISTAXIS 0 (0.0) 1 (1.0) 2 (2.8) 3 (1.2)
PHARYNGOLARYNGEAL PAIN 0 (0.0) 1 (1.0) 1 (1.4) 2 (0.8)
PSYCHIATRIC DISORDERS 7 (8.1) 9 (9.4) 3 (4.2) 19 (7.5)
CONFUSIONAL STATE 2 (2.3) 3 (3.1) 1 (1.4) 6 (2.4)
AGITATION 2 (2.3) 3 (3.1) 0 (0.0) 5 (2.0)
INSOMNIA 2 (2.3) 0 (0.0) 2 (2.8) 4 (1.6)
ANXIETY 0 (0.0) 3 (3.1) 0 (0.0) 3 (1.2)
DELUSION 1 (1.2) 0 (0.0) 1 (1.4) 2 (0.8)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS 3 (3.5) 6 (6.2) 5 (6.9) 14 (5.5)
BACK PAIN 1 (1.2) 1 (1.0) 3 (4.2) 5 (2.0)
ARTHRALGIA 1 (1.2) 2 (2.1) 1 (1.4) 4 (1.6)
SHOULDER PAIN 1 (1.2) 2 (2.1) 0 (0.0) 3 (1.2)
MUSCLE SPASMS 0 (0.0) 1 (1.0) 1 (1.4) 2 (0.8)
ARTHRITIS 0 (0.0) 0 (0.0) 1 (1.4) 1 (0.4)
INVESTIGATIONS 5 (5.8) 4 (4.2) 3 (4.2) 12 (4.7)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7) 1 (1.0) 0 (0.0) 5 (2.0)
ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3) 1 (1.0) 1 (1.4) 4 (1.6)
BLOOD GLUCOSE INCREASED 0 (0.0) 1 (1.0) 1 (1.4) 2 (0.8)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2) 1 (1.0) 0 (0.0) 2 (0.8)
BIOPSY 0 (0.0) 0 (0.0) 1 (1.4) 1 (0.4)
Subjects are counted once per SOC and once per PT.

# ---- Example 2: Wide ACROSS-style efficacy table split across 2 panels ----
#
# BOR table where the four-arm column block is too wide for portrait
# paper. Split into 2 horizontal panels; the group column
# (`stat_label`) repeats on every panel for row context. Vertical
# pagination still applies, so on a tall table you would see panel A
# pages 1-2, then panel B pages 1-2.
bor_levels <- c(
  "CR", "PR", "SD", "NON-CR/NON-PD", "PD", "NE", "MISSING",
  "ORR (CR + PR)", "CBR (CR + PR + SD)",
  "DCR (CR + PR + SD + NON-CR/NON-PD)", "95% CI (Clopper-Pearson)"
)
eff <- cdisc_eff_resp
eff$stat_label <- factor(eff$stat_label, levels = bor_levels)
ne <- stats::setNames(cdisc_eff_n$n, cdisc_eff_n$arm_short)

tabular(
  eff,
  titles = c(
    "Table 14.2.1",
    "Best Overall Response and Response Rates",
    "Efficacy Evaluable Population"
  ),
  footnotes = "Response per RECIST 1.1, investigator assessment."
) |>
  cols(
    stat_label  = col_spec(usage = "id", label = "Response"),
    row_type    = col_spec(visible = FALSE),
    groupid     = col_spec(visible = FALSE),
    group_label = col_spec(visible = FALSE),
    placebo    = col_spec(label = "Placebo\nN={ne['placebo']}"),
    drug_50    = col_spec(label = "Drug 50\nN={ne['drug_50']}"),
    drug_100   = col_spec(label = "Drug 100\nN={ne['drug_100']}")
  ) |>
  sort_rows(by = c("groupid", "stat_label")) |>
  paginate(panels = 2, repeat_content = c("titles", "headers", "footnotes"))
 
Table 14.2.1
Best Overall Response and Response Rates
Efficacy Evaluable Population
 

Panel 1 Panel 2
Response Placebo
N=86 Drug 50
N=84 Drug 100
N=84
CR 1 (1.2) 1 (1.2) 1 (1.2)
PR 1 (1.2) 0 0
SD 1 (1.2) 0 0
NON-CR/NON-PD 0 0 1 (1.2)
PD 0 0 1 (1.2)
NE 0 1 (1.2) 0
MISSING 83 (96.5) 82 (97.6) 81 (96.4)
ORR (CR + PR) 2 (2.3) 1 (1.2) 1 (1.2)
95% CI (Clopper-Pearson) (0.3, 8.1) (0.0, 6.5) (0.0, 6.5)
CBR (CR + PR + SD) 3 (3.5) 1 (1.2) 1 (1.2)
95% CI (Clopper-Pearson) (0.7, 9.9) (0.0, 6.5) (0.0, 6.5)
DCR (CR + PR + SD + NON-CR/NON-PD) 3 (3.5) 1 (1.2) 2 (2.4)
95% CI (Clopper-Pearson) (0.7, 9.9) (0.0, 6.5) (0.3, 8.3)
Response per RECIST 1.1, investigator assessment.

# ---- Example 3: Orphan / widow floors + continuation marker ----
#
# Long vital-signs table with two safeguards: orphan_floor = 4
# prevents fewer than 4 rows of a group landing alone at the
# bottom of a page; widow_floor = 2 prevents fewer than 2 rows of
# a group landing alone at the top of the next page; the
# continuation marker prints on every page after the first.
tabular(
  cdisc_saf_vital,
  titles = c("Table 14.4.1", "Vital Signs Summary at Each Visit")
) |>
  cols(
    param      = col_spec(usage = "group", label = "Parameter"),
    paramcd    = col_spec(visible = FALSE),
    visit      = col_spec(usage = "group", label = "Visit"),
    stat_label = col_spec(label = "Statistic"),
    placebo    = col_spec(label = "Placebo",  align = "decimal"),
    drug_50    = col_spec(label = "Drug 50",  align = "decimal"),
    drug_100   = col_spec(label = "Drug 100", align = "decimal")
  ) |>
  paginate(
    keep_together = "param",
    orphan_floor  = 4L,
    widow_floor   = 2L,
    continuation  = "(continued)"
  )
 
Table 14.4.1
Vital Signs Summary at Each Visit
 

Statistic Placebo Drug 50 Drug 100
Diastolic Blood Pressure (mmHg)
Baseline
n 340          384          288         
Mean (SD)  77.1 (10.7)  76.6 (9.8)   78.2 (10.3)
Median  77.7         76.7         78.8       
Min, Max  40  , 110    48  , 108    51  , 108  
 
Week 8
n 292          240          224         
Mean (SD)  75.2 (9.1)   75.4 (10.6)  77.4 (9.1) 
Median  76.0         74.0         78.3       
Min, Max  49  , 101    52  , 100    54  , 98   
 
Week 16
n 272          168          148         
Mean (SD)  75.1 (10.9)  75.2 (10.0)  76.0 (9.0) 
Median  76.0         75.7         77.3       
Min, Max  49  , 98     55  , 98     50  , 92   
 
End of Treatment
n 222          177          168         
Mean (SD)  74.4 (10.7)  76.0 (11.2)  76.0 (9.9) 
Median  73.5         76.0         78.0       
Min, Max  49  , 104    50  , 100    56  , 98   
 
Pulse Rate (beats/min)
Baseline
n 340          384          288         
Mean (SD)  73.5 (11.6)  72.1 (10.8)  72.4 (9.7) 
Median  72.3         70.0         71.7       
Min, Max  51  , 134    50  , 104    52  , 100  
 
Week 8
n 292          240          224         
Mean (SD)  71.8 (9.0)   72.6 (11.1)  74.0 (8.9) 
Median  72.0         72.0         73.2       
Min, Max  52  , 102    49  , 104    50  , 104  
 
Week 16
n 272          168          148         
Mean (SD)  70.6 (8.8)   68.8 (9.4)   73.2 (9.5) 
Median  70.2         68.0         72.0       
Min, Max  50  , 90     48  , 104    51  , 96   
 
End of Treatment
n 222          177          168         
Mean (SD)  75.2 (11.5)  74.1 (9.4)   73.6 (9.6) 
Median  74.0         75.0         73.0       
Min, Max  51  , 106    50  , 94     50  , 98   
Systolic Blood Pressure (mmHg)
Baseline
n 340          384          288         
Mean (SD) 136.8 (17.6) 137.9 (18.5) 137.8 (17.2)
Median 136.3        138.0        138.0       
Min, Max  80  , 184   100  , 194   100  , 192  
 
Week 8
n 292          240          224         
Mean (SD) 136.3 (17.0) 134.9 (17.8) 135.1 (15.5)
Median 136.5        132.3        134.0       
Min, Max  90  , 189    92  , 200    91  , 198  
 
Week 16
n 272          168          148         
Mean (SD) 134.6 (18.3) 132.5 (14.3) 133.7 (16.0)
Median 134.0        130.0        132.0       
Min, Max  76  , 190   100  , 168    99  , 186  
 
End of Treatment
n 222          177          168         
Mean (SD) 132.7 (15.4) 133.0 (17.1) 132.3 (15.6)
Median 131.0        130.0        131.0       
Min, Max  78  , 172    92  , 178   100  , 177  
 
Temperature (C)
Baseline
n 172          190          144         
Mean (SD)  36.6 (0.4)   36.5 (0.4)   36.6 (0.4) 
Median  36.7         36.6         36.6       
Min, Max  35  , 37     35  , 37     36  , 37   
 
Week 8
n 146          118          112         
Mean (SD)  36.6 (0.4)   36.6 (0.4)   36.6 (0.4) 
Median  36.6         36.7         36.7       
Min, Max  36  , 37     36  , 37     36  , 37   
 
Week 16
n 136           82           74         
Mean (SD)  36.7 (0.3)   36.6 (0.4)   36.6 (0.4) 
Median  36.7         36.6         36.7       
Min, Max  36  , 37     36  , 37     36  , 37   
 
End of Treatment
n  74           59           56         
Mean (SD)  36.7 (0.4)   36.6 (0.4)   36.6 (0.4) 
Median  36.8         36.7         36.7       
Min, Max  35  , 37     35  , 38     36  , 37   

# ---- Example 4: Many-arm horizontal pagination via column-fit ----
#
# Wide AE-by-SOC/PT table where the column strip itself does not
# fit on a single page. The engine slices columns into groups
# (each group keeping the `usage = "group"` columns repeated on
# every horizontal page) so the SOC / PT label band re-appears
# alongside whichever arm columns land on each panel.
tabular(
  cdisc_saf_aesocpt,
  titles = c("Table 14.3.1", "AEs by SOC and PT (wide-page split)")
) |>
  cols(
    label    = col_spec(label = "SOC / PT", indent = "indent_level",
                        width = "2.5in"),
    soc      = col_spec(usage = "group", visible = FALSE,
                        group_display = "column_repeat"),
    soc_n    = col_spec(visible = FALSE),
    n_total  = col_spec(visible = FALSE),
    row_type = col_spec(visible = FALSE),
    placebo  = col_spec(label = "Placebo",  align = "decimal",
                        width = "2.0in"),
    drug_50  = col_spec(label = "Drug 50",  align = "decimal",
                        width = "2.0in"),
    drug_100 = col_spec(label = "Drug 100", align = "decimal",
                        width = "2.0in"),
    Total    = col_spec(label = "Total",    align = "decimal",
                        width = "2.0in")
  ) |>
  paginate(keep_together = "soc")
 
Table 14.3.1
AEs by SOC and PT (wide-page split)
 

SOC / PT Placebo Drug 50 Drug 100 Total
TOTAL SUBJECTS WITH AN EVENT 52 (60.5) 81 (84.4) 66 (91.7) 199 (78.3)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 19 (22.1) 36 (37.5) 35 (48.6)  90 (35.4)
PRURITUS  8 ( 9.3) 21 (21.9) 25 (34.7)  54 (21.3)
ERYTHEMA  8 ( 9.3) 14 (14.6) 14 (19.4)  36 (14.2)
RASH  5 ( 5.8) 13 (13.5)  8 (11.1)  26 (10.2)
HYPERHIDROSIS  2 ( 2.3)  4 ( 4.2)  8 (11.1)  14 ( 5.5)
SKIN IRRITATION  3 ( 3.5)  6 ( 6.2)  5 ( 6.9)  14 ( 5.5)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 15 (17.4) 36 (37.5) 30 (41.7)  81 (31.9)
APPLICATION SITE PRURITUS  6 ( 7.0) 23 (24.0) 21 (29.2)  50 (19.7)
APPLICATION SITE ERYTHEMA  3 ( 3.5) 13 (13.5) 14 (19.4)  30 (11.8)
APPLICATION SITE DERMATITIS  5 ( 5.8)  9 ( 9.4)  7 ( 9.7)  21 ( 8.3)
APPLICATION SITE IRRITATION  3 ( 3.5)  9 ( 9.4)  9 (12.5)  21 ( 8.3)
APPLICATION SITE VESICLES  1 ( 1.2)  5 ( 5.2)  5 ( 6.9)  11 ( 4.3)
GASTROINTESTINAL DISORDERS 13 (15.1) 12 (12.5) 17 (23.6)  42 (16.5)
DIARRHOEA  9 (10.5)  5 ( 5.2)  3 ( 4.2)  17 ( 6.7)
VOMITING  3 ( 3.5)  4 ( 4.2)  6 ( 8.3)  13 ( 5.1)
NAUSEA  3 ( 3.5)  3 ( 3.1)  6 ( 8.3)  12 ( 4.7)
ABDOMINAL PAIN  1 ( 1.2)  3 ( 3.1)  1 ( 1.4)   5 ( 2.0)
SALIVARY HYPERSECRETION  0         0         4 ( 5.6)   4 ( 1.6)
NERVOUS SYSTEM DISORDERS  6 ( 7.0) 18 (18.8) 17 (23.6)  41 (16.1)
DIZZINESS  2 ( 2.3)  9 ( 9.4) 10 (13.9)  21 ( 8.3)
HEADACHE  3 ( 3.5)  3 ( 3.1)  5 ( 6.9)  11 ( 4.3)
SYNCOPE  0         5 ( 5.2)  2 ( 2.8)   7 ( 2.8)
SOMNOLENCE  2 ( 2.3)  3 ( 3.1)  1 ( 1.4)   6 ( 2.4)
TRANSIENT ISCHAEMIC ATTACK  0         2 ( 2.1)  1 ( 1.4)   3 ( 1.2)
CARDIAC DISORDERS  7 ( 8.1) 12 (12.5) 14 (19.4)  33 (13.0)
SINUS BRADYCARDIA  2 ( 2.3)  7 ( 7.3)  8 (11.1)  17 ( 6.7)
MYOCARDIAL INFARCTION  4 ( 4.7)  2 ( 2.1)  4 ( 5.6)  10 ( 3.9)
ATRIAL FIBRILLATION  1 ( 1.2)  2 ( 2.1)  2 ( 2.8)   5 ( 2.0)
SUPRAVENTRICULAR EXTRASYSTOLES  1 ( 1.2)  1 ( 1.0)  1 ( 1.4)   3 ( 1.2)
VENTRICULAR EXTRASYSTOLES  0         2 ( 2.1)  1 ( 1.4)   3 ( 1.2)
INFECTIONS AND INFESTATIONS 12 (14.0)  6 ( 6.2) 11 (15.3)  29 (11.4)
NASOPHARYNGITIS  2 ( 2.3)  4 ( 4.2)  6 ( 8.3)  12 ( 4.7)
UPPER RESPIRATORY TRACT INFECTION  6 ( 7.0)  1 ( 1.0)  3 ( 4.2)  10 ( 3.9)
INFLUENZA  1 ( 1.2)  1 ( 1.0)  1 ( 1.4)   3 ( 1.2)
URINARY TRACT INFECTION  2 ( 2.3)  0         1 ( 1.4)   3 ( 1.2)
CYSTITIS  1 ( 1.2)  0         1 ( 1.4)   2 ( 0.8)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS  5 ( 5.8)  8 ( 8.3)  9 (12.5)  22 ( 8.7)
COUGH  1 ( 1.2)  5 ( 5.2)  5 ( 6.9)  11 ( 4.3)
NASAL CONGESTION  3 ( 3.5)  1 ( 1.0)  3 ( 4.2)   7 ( 2.8)
DYSPNOEA  1 ( 1.2)  1 ( 1.0)  1 ( 1.4)   3 ( 1.2)
EPISTAXIS  0         1 ( 1.0)  2 ( 2.8)   3 ( 1.2)
PHARYNGOLARYNGEAL PAIN  0         1 ( 1.0)  1 ( 1.4)   2 ( 0.8)
PSYCHIATRIC DISORDERS  7 ( 8.1)  9 ( 9.4)  3 ( 4.2)  19 ( 7.5)
CONFUSIONAL STATE  2 ( 2.3)  3 ( 3.1)  1 ( 1.4)   6 ( 2.4)
AGITATION  2 ( 2.3)  3 ( 3.1)  0          5 ( 2.0)
INSOMNIA  2 ( 2.3)  0         2 ( 2.8)   4 ( 1.6)
ANXIETY  0         3 ( 3.1)  0          3 ( 1.2)
DELUSION  1 ( 1.2)  0         1 ( 1.4)   2 ( 0.8)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS  3 ( 3.5)  6 ( 6.2)  5 ( 6.9)  14 ( 5.5)
BACK PAIN  1 ( 1.2)  1 ( 1.0)  3 ( 4.2)   5 ( 2.0)
ARTHRALGIA  1 ( 1.2)  2 ( 2.1)  1 ( 1.4)   4 ( 1.6)
SHOULDER PAIN  1 ( 1.2)  2 ( 2.1)  0          3 ( 1.2)
MUSCLE SPASMS  0         1 ( 1.0)  1 ( 1.4)   2 ( 0.8)
ARTHRITIS  0         0         1 ( 1.4)   1 ( 0.4)
INVESTIGATIONS  5 ( 5.8)  4 ( 4.2)  3 ( 4.2)  12 ( 4.7)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION  4 ( 4.7)  1 ( 1.0)  0          5 ( 2.0)
ELECTROCARDIOGRAM T WAVE INVERSION  2 ( 2.3)  1 ( 1.0)  1 ( 1.4)   4 ( 1.6)
BLOOD GLUCOSE INCREASED  0         1 ( 1.0)  1 ( 1.4)   2 ( 0.8)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED  1 ( 1.2)  1 ( 1.0)  0          2 ( 0.8)
BIOPSY  0         0         1 ( 1.4)   1 ( 0.4)

	Treatment Group
SOC / PT	Placebo N=86	Drug 50 N=96	Drug 100 N=72	Total N=254
TOTAL SUBJECTS WITH AN EVENT	52 (60.5)	81 (84.4)	66 (91.7)	199 (78.3)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS	19 (22.1)	36 (37.5)	35 (48.6)	90 (35.4)
PRURITUS	8 (9.3)	21 (21.9)	25 (34.7)	54 (21.3)
ERYTHEMA	8 (9.3)	14 (14.6)	14 (19.4)	36 (14.2)
RASH	5 (5.8)	13 (13.5)	8 (11.1)	26 (10.2)
HYPERHIDROSIS	2 (2.3)	4 (4.2)	8 (11.1)	14 (5.5)
SKIN IRRITATION	3 (3.5)	6 (6.2)	5 (6.9)	14 (5.5)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	15 (17.4)	36 (37.5)	30 (41.7)	81 (31.9)
APPLICATION SITE PRURITUS	6 (7.0)	23 (24.0)	21 (29.2)	50 (19.7)
APPLICATION SITE ERYTHEMA	3 (3.5)	13 (13.5)	14 (19.4)	30 (11.8)
APPLICATION SITE DERMATITIS	5 (5.8)	9 (9.4)	7 (9.7)	21 (8.3)
APPLICATION SITE IRRITATION	3 (3.5)	9 (9.4)	9 (12.5)	21 (8.3)
APPLICATION SITE VESICLES	1 (1.2)	5 (5.2)	5 (6.9)	11 (4.3)
GASTROINTESTINAL DISORDERS	13 (15.1)	12 (12.5)	17 (23.6)	42 (16.5)
DIARRHOEA	9 (10.5)	5 (5.2)	3 (4.2)	17 (6.7)
VOMITING	3 (3.5)	4 (4.2)	6 (8.3)	13 (5.1)
NAUSEA	3 (3.5)	3 (3.1)	6 (8.3)	12 (4.7)
ABDOMINAL PAIN	1 (1.2)	3 (3.1)	1 (1.4)	5 (2.0)
SALIVARY HYPERSECRETION	0 (0.0)	0 (0.0)	4 (5.6)	4 (1.6)
NERVOUS SYSTEM DISORDERS	6 (7.0)	18 (18.8)	17 (23.6)	41 (16.1)
DIZZINESS	2 (2.3)	9 (9.4)	10 (13.9)	21 (8.3)
HEADACHE	3 (3.5)	3 (3.1)	5 (6.9)	11 (4.3)
SYNCOPE	0 (0.0)	5 (5.2)	2 (2.8)	7 (2.8)
SOMNOLENCE	2 (2.3)	3 (3.1)	1 (1.4)	6 (2.4)
TRANSIENT ISCHAEMIC ATTACK	0 (0.0)	2 (2.1)	1 (1.4)	3 (1.2)

CARDIAC DISORDERS	7 (8.1)	12 (12.5)	14 (19.4)	33 (13.0)
SINUS BRADYCARDIA	2 (2.3)	7 (7.3)	8 (11.1)	17 (6.7)
MYOCARDIAL INFARCTION	4 (4.7)	2 (2.1)	4 (5.6)	10 (3.9)
ATRIAL FIBRILLATION	1 (1.2)	2 (2.1)	2 (2.8)	5 (2.0)
SUPRAVENTRICULAR EXTRASYSTOLES	1 (1.2)	1 (1.0)	1 (1.4)	3 (1.2)
VENTRICULAR EXTRASYSTOLES	0 (0.0)	2 (2.1)	1 (1.4)	3 (1.2)
INFECTIONS AND INFESTATIONS	12 (14.0)	6 (6.2)	11 (15.3)	29 (11.4)
NASOPHARYNGITIS	2 (2.3)	4 (4.2)	6 (8.3)	12 (4.7)
UPPER RESPIRATORY TRACT INFECTION	6 (7.0)	1 (1.0)	3 (4.2)	10 (3.9)
INFLUENZA	1 (1.2)	1 (1.0)	1 (1.4)	3 (1.2)
URINARY TRACT INFECTION	2 (2.3)	0 (0.0)	1 (1.4)	3 (1.2)
CYSTITIS	1 (1.2)	0 (0.0)	1 (1.4)	2 (0.8)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	5 (5.8)	8 (8.3)	9 (12.5)	22 (8.7)
COUGH	1 (1.2)	5 (5.2)	5 (6.9)	11 (4.3)
NASAL CONGESTION	3 (3.5)	1 (1.0)	3 (4.2)	7 (2.8)
DYSPNOEA	1 (1.2)	1 (1.0)	1 (1.4)	3 (1.2)
EPISTAXIS	0 (0.0)	1 (1.0)	2 (2.8)	3 (1.2)
PHARYNGOLARYNGEAL PAIN	0 (0.0)	1 (1.0)	1 (1.4)	2 (0.8)
PSYCHIATRIC DISORDERS	7 (8.1)	9 (9.4)	3 (4.2)	19 (7.5)
CONFUSIONAL STATE	2 (2.3)	3 (3.1)	1 (1.4)	6 (2.4)
AGITATION	2 (2.3)	3 (3.1)	0 (0.0)	5 (2.0)
INSOMNIA	2 (2.3)	0 (0.0)	2 (2.8)	4 (1.6)
ANXIETY	0 (0.0)	3 (3.1)	0 (0.0)	3 (1.2)
DELUSION	1 (1.2)	0 (0.0)	1 (1.4)	2 (0.8)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	3 (3.5)	6 (6.2)	5 (6.9)	14 (5.5)
BACK PAIN	1 (1.2)	1 (1.0)	3 (4.2)	5 (2.0)
ARTHRALGIA	1 (1.2)	2 (2.1)	1 (1.4)	4 (1.6)
SHOULDER PAIN	1 (1.2)	2 (2.1)	0 (0.0)	3 (1.2)
MUSCLE SPASMS	0 (0.0)	1 (1.0)	1 (1.4)	2 (0.8)
ARTHRITIS	0 (0.0)	0 (0.0)	1 (1.4)	1 (0.4)
INVESTIGATIONS	5 (5.8)	4 (4.2)	3 (4.2)	12 (4.7)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	4 (4.7)	1 (1.0)	0 (0.0)	5 (2.0)
ELECTROCARDIOGRAM T WAVE INVERSION	2 (2.3)	1 (1.0)	1 (1.4)	4 (1.6)
BLOOD GLUCOSE INCREASED	0 (0.0)	1 (1.0)	1 (1.4)	2 (0.8)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	1 (1.2)	1 (1.0)	0 (0.0)	2 (0.8)
BIOPSY	0 (0.0)	0 (0.0)	1 (1.4)	1 (0.4)

	Panel 1		Panel 2
Response	Placebo N=86	Drug 50 N=84	Drug 100 N=84
CR	1 (1.2)	1 (1.2)	1 (1.2)
PR	1 (1.2)	0	0
SD	1 (1.2)	0	0
NON-CR/NON-PD	0	0	1 (1.2)
PD	0	0	1 (1.2)
NE	0	1 (1.2)	0
MISSING	83 (96.5)	82 (97.6)	81 (96.4)
ORR (CR + PR)	2 (2.3)	1 (1.2)	1 (1.2)
95% CI (Clopper-Pearson)	(0.3, 8.1)	(0.0, 6.5)	(0.0, 6.5)
CBR (CR + PR + SD)	3 (3.5)	1 (1.2)	1 (1.2)
95% CI (Clopper-Pearson)	(0.7, 9.9)	(0.0, 6.5)	(0.0, 6.5)
DCR (CR + PR + SD + NON-CR/NON-PD)	3 (3.5)	1 (1.2)	2 (2.4)
95% CI (Clopper-Pearson)	(0.7, 9.9)	(0.0, 6.5)	(0.3, 8.3)

Statistic	Placebo	Drug 50	Drug 100
Diastolic Blood Pressure (mmHg)
Baseline
n	340	384	288
Mean (SD)	77.1 (10.7)	76.6 (9.8)	78.2 (10.3)
Median	77.7	76.7	78.8
Min, Max	40 , 110	48 , 108	51 , 108

Week 8
n	292	240	224
Mean (SD)	75.2 (9.1)	75.4 (10.6)	77.4 (9.1)
Median	76.0	74.0	78.3
Min, Max	49 , 101	52 , 100	54 , 98

Week 16
n	272	168	148
Mean (SD)	75.1 (10.9)	75.2 (10.0)	76.0 (9.0)
Median	76.0	75.7	77.3
Min, Max	49 , 98	55 , 98	50 , 92

End of Treatment
n	222	177	168
Mean (SD)	74.4 (10.7)	76.0 (11.2)	76.0 (9.9)
Median	73.5	76.0	78.0
Min, Max	49 , 104	50 , 100	56 , 98

Pulse Rate (beats/min)
Baseline
n	340	384	288
Mean (SD)	73.5 (11.6)	72.1 (10.8)	72.4 (9.7)
Median	72.3	70.0	71.7
Min, Max	51 , 134	50 , 104	52 , 100

Week 8
n	292	240	224
Mean (SD)	71.8 (9.0)	72.6 (11.1)	74.0 (8.9)
Median	72.0	72.0	73.2
Min, Max	52 , 102	49 , 104	50 , 104

Week 16
n	272	168	148
Mean (SD)	70.6 (8.8)	68.8 (9.4)	73.2 (9.5)
Median	70.2	68.0	72.0
Min, Max	50 , 90	48 , 104	51 , 96

End of Treatment
n	222	177	168
Mean (SD)	75.2 (11.5)	74.1 (9.4)	73.6 (9.6)
Median	74.0	75.0	73.0
Min, Max	51 , 106	50 , 94	50 , 98

Systolic Blood Pressure (mmHg)
Baseline
n	340	384	288
Mean (SD)	136.8 (17.6)	137.9 (18.5)	137.8 (17.2)
Median	136.3	138.0	138.0
Min, Max	80 , 184	100 , 194	100 , 192

Week 8
n	292	240	224
Mean (SD)	136.3 (17.0)	134.9 (17.8)	135.1 (15.5)
Median	136.5	132.3	134.0
Min, Max	90 , 189	92 , 200	91 , 198

Week 16
n	272	168	148
Mean (SD)	134.6 (18.3)	132.5 (14.3)	133.7 (16.0)
Median	134.0	130.0	132.0
Min, Max	76 , 190	100 , 168	99 , 186

End of Treatment
n	222	177	168
Mean (SD)	132.7 (15.4)	133.0 (17.1)	132.3 (15.6)
Median	131.0	130.0	131.0
Min, Max	78 , 172	92 , 178	100 , 177

Temperature (C)
Baseline
n	172	190	144
Mean (SD)	36.6 (0.4)	36.5 (0.4)	36.6 (0.4)
Median	36.7	36.6	36.6
Min, Max	35 , 37	35 , 37	36 , 37

Week 8
n	146	118	112
Mean (SD)	36.6 (0.4)	36.6 (0.4)	36.6 (0.4)
Median	36.6	36.7	36.7
Min, Max	36 , 37	36 , 37	36 , 37

Week 16
n	136	82	74
Mean (SD)	36.7 (0.3)	36.6 (0.4)	36.6 (0.4)
Median	36.7	36.6	36.7
Min, Max	36 , 37	36 , 37	36 , 37

End of Treatment
n	74	59	56
Mean (SD)	36.7 (0.4)	36.6 (0.4)	36.6 (0.4)
Median	36.8	36.7	36.7
Min, Max	35 , 37	35 , 38	36 , 37

Usage

Arguments

Value

Details

See also

Examples