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Safety Summary (AET01)
1. Safety Summary
The aet01 template produces the
standard safety summary.
run(aet01, syn_data, arm_var = "ARM")
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of AEs 609 622 703
#> Total number of deaths 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> Total number of patients withdrawn from study due to an AE 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> Total number of patients with at least one
#> AE with fatal outcome 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> Serious AE 104 (77.6%) 101 (75.4%) 99 (75.0%)
#> Serious AE leading to withdrawal from treatment 9 (6.7%) 6 (4.5%) 11 (8.3%)
#> Serious AE leading to dose modification/interruption 22 (16.4%) 26 (19.4%) 29 (22.0%)
#> Related Serious AE 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> AE leading to withdrawal from treatment 27 (20.1%) 26 (19.4%) 30 (22.7%)
#> AE leading to dose modification/interruption 66 (49.3%) 76 (56.7%) 74 (56.1%)
#> Related AE 105 (78.4%) 108 (80.6%) 109 (82.6%)
#> Related AE leading to withdrawal from treatment 6 (4.5%) 12 (9.0%) 8 (6.1%)
#> Related AE leading to dose modification/interruption 29 (21.6%) 38 (28.4%) 38 (28.8%)
#> Severe AE (at greatest intensity) 91 (67.9%) 90 (67.2%) 93 (70.5%)2. Safety Summary with Modified Rows
Analyses under “Total number of patients with at least one” can be
removed, added, or modified by editing the parameter
anl_vars. An analyses here is an abbreviated name of the
analyses of interest, and supported by a variable in ADAE
derived under the condition of interest. The defined analyses currently
include "FATAL", "SER", "SERWD",
"SERDSM", "RELSER", "WD",
"DSM", "REL", "RELWD",
"RELDSM", and "SEV". When modification is
made, analyses must be all listed in the parameter
anl_vars. The example below shows adding customized
analyses "RELCTC35".
proc_data <- syn_data
proc_data$adae <- proc_data$adae %>%
filter(.data$ANL01FL == "Y") %>%
mutate(
FATAL = with_label(.data$AESDTH == "Y", "AE with fatal outcome"),
SER = with_label(.data$AESER == "Y", "Serious AE"),
SEV = with_label(.data$ASEV == "SEVERE", "Severe AE (at greatest intensity)"),
REL = with_label(.data$AREL == "Y", "Related AE"),
WD = with_label(.data$AEACN == "DRUG WITHDRAWN", "AE leading to withdrawal from treatment"),
DSM = with_label(
.data$AEACN %in% c("DRUG INTERRUPTED", "DOSE INCREASED", "DOSE REDUCED"),
"AE leading to dose modification/interruption"
),
SERWD = with_label(.data$SER & .data$WD, "Serious AE leading to withdrawal from treatment"),
SERDSM = with_label(.data$SER & .data$DSM, "Serious AE leading to dose modification/interruption"),
RELSER = with_label(.data$SER & .data$REL, "Related Serious AE"),
RELWD = with_label(.data$REL & .data$WD, "Related AE leading to withdrawal from treatment"),
RELDSM = with_label(.data$REL & .data$DSM, "Related AE leading to dose modification/interruption"),
CTC35 = with_label(.data$ATOXGR %in% c("3", "4", "5"), "Grade 3-5 AE"),
CTC45 = with_label(.data$ATOXGR %in% c("4", "5"), "Grade 4/5 AE"),
RELCTC35 = with_label(.data$ATOXGR %in% c("3", "4", "5") & .data$AEREL == "Y", "Related Grade 3-5")
)
proc_data$adsl <- proc_data$adsl %>%
mutate(DCSREAS = reformat(.data$DCSREAS, missing_rule))
run(aet01, proc_data, anl_vars = list(safety_var = c("FATAL", "SER", "RELSER", "RELCTC35")), auto_pre = FALSE)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of AEs 609 622 703
#> Total number of deaths 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> Total number of patients withdrawn from study due to an AE 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> Total number of patients with at least one
#> AE with fatal outcome 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> Serious AE 104 (77.6%) 101 (75.4%) 99 (75.0%)
#> Related Serious AE 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> Related Grade 3-5 91 (67.9%) 90 (67.2%) 93 (70.5%)
Safety Summary (Adverse Events of Special Interest)
(AET01_AESI)
1. Safety Summary (Adverse Events of Special Interest)
The aet01_aesi template produces the
standard safety summary for adverse events of special interest.
run(aet01_aesi, syn_data)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of AEs 609 622 703
#> Total number of patients with at least one AE by worst grade
#> Grade 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> Total number of patients with study drug withdrawn due to AE 27 (20.1%) 26 (19.4%) 30 (22.7%)
#> Total number of patients with dose modified/interrupted due to AE 66 (49.3%) 76 (56.7%) 74 (56.1%)
#> Total number of patients with treatment received for AE 98 (73.1%) 102 (76.1%) 103 (78.0%)
#> Total number of patients with all non-fatal AEs resolved 84 (62.7%) 92 (68.7%) 97 (73.5%)
#> Total number of patients with at least one unresolved or ongoing non-fatal AE 102 (76.1%) 110 (82.1%) 107 (81.1%)
#> Total number of patients with at least one serious AE 104 (77.6%) 101 (75.4%) 99 (75.0%)
#> Total number of patients with at least one related AE 105 (78.4%) 108 (80.6%) 109 (82.6%)2. Safety Summary (Adverse Events of Special Interest) (optional lines)
Additional analyses can be added with the parameter
aesi_vars, please type ?aet01_aesi in console
to find out the list of all pre-defined optional analyses in the
HELP.
run(aet01_aesi, syn_data, aesi_vars = c("RESLWD", "RELSER"))
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one AE 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of AEs 609 622 703
#> Total number of patients with at least one AE by worst grade
#> Grade 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> Total number of patients with study drug withdrawn due to AE 27 (20.1%) 26 (19.4%) 30 (22.7%)
#> Total number of patients with dose modified/interrupted due to AE 66 (49.3%) 76 (56.7%) 74 (56.1%)
#> Total number of patients with treatment received for AE 98 (73.1%) 102 (76.1%) 103 (78.0%)
#> Total number of patients with all non-fatal AEs resolved 84 (62.7%) 92 (68.7%) 97 (73.5%)
#> Total number of patients with at least one unresolved or ongoing non-fatal AE 102 (76.1%) 110 (82.1%) 107 (81.1%)
#> Total number of patients with at least one serious AE 104 (77.6%) 101 (75.4%) 99 (75.0%)
#> Total number of patients with at least one related AE 105 (78.4%) 108 (80.6%) 109 (82.6%)
#> No. of patients with serious, related AE 76 (56.7%) 70 (52.2%) 75 (56.8%)
Adverse Events (AET02)
1. Adverse Events
- The template
aet02produces the standard adverse event summary by MedDRA system organ class and preferred term. - The template does not include the column of total as default. The
‘All Patients’ column can be added by
lbl_overall = "All Patients". - Missing values in
"AEBODSYS", and"AEDECOD"are labeled byNo Coding Available.
run(aet02, syn_data)
#> MedDRA System Organ Class A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————
#> Overall total number of events 609 622 703
#> Total number of patients with at least one adverse event 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> cl A.1
#> Total number of patients with at least one adverse event 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of events 132 130 160
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> Total number of patients with at least one adverse event 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Total number of events 129 138 143
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> Total number of patients with at least one adverse event 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Total number of events 127 106 135
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> Total number of patients with at least one adverse event 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Total number of events 62 72 74
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> Total number of patients with at least one adverse event 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Total number of events 56 60 62
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> Total number of patients with at least one adverse event 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Total number of events 48 53 65
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> Total number of patients with at least one adverse event 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Total number of events 55 63 64
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)2. Adverse Events (with High-level Term)
The syntax below displays adverse events by MedDRA system organ class, high-level term and preferred term.
run(aet02, syn_data, row_split_var = c("AEBODSYS", "AEHLT"))
#> MedDRA System Organ Class
#> High Level Term A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Overall total number of events 609 622 703
#> Total number of patients with at least one adverse event 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> cl A.1
#> Total number of patients with at least one adverse event 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of events 132 130 160
#> hlt A.1.1.1
#> Total number of patients with at least one adverse event 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of events 132 130 160
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> Total number of patients with at least one adverse event 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Total number of events 129 138 143
#> hlt B.2.2.3
#> Total number of patients with at least one adverse event 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Total number of events 64 76 77
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> hlt B.2.1.2
#> Total number of patients with at least one adverse event 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Total number of events 65 62 66
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> Total number of patients with at least one adverse event 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Total number of events 127 106 135
#> hlt D.1.1.1
#> Total number of patients with at least one adverse event 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Total number of events 61 51 71
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> hlt D.1.1.4
#> Total number of patients with at least one adverse event 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Total number of events 66 55 64
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> Total number of patients with at least one adverse event 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Total number of events 62 72 74
#> hlt D.2.1.5
#> Total number of patients with at least one adverse event 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Total number of events 62 72 74
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> Total number of patients with at least one adverse event 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Total number of events 56 60 62
#> hlt B.1.1.1
#> Total number of patients with at least one adverse event 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Total number of events 56 60 62
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> Total number of patients with at least one adverse event 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Total number of events 48 53 65
#> hlt C.2.1.2
#> Total number of patients with at least one adverse event 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Total number of events 48 53 65
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> Total number of patients with at least one adverse event 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Total number of events 55 63 64
#> hlt C.1.1.1
#> Total number of patients with at least one adverse event 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Total number of events 55 63 64
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)3. Adverse Events (Preferred Terms only)
The syntax below displays adverse events by preferred term only.
run(aet02, syn_data, row_split_var = NULL)
#> MedDRA Preferred Term A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————
#> Overall total number of events 609 622 703
#> Total number of patients with at least one adverse event 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)
Adverse Events by Greatest
Intensity(AET03)
1. Adverse Events by Greatest Intensity
This aet03 template produces the
standard adverse event by greatest intensity summary
run(aet03, syn_data)
#> MedDRA System Organ Class A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————
#> - Any Intensity - 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> MILD 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> MODERATE 24 (17.9%) 24 (17.9%) 23 (17.4%)
#> SEVERE 91 (67.9%) 90 (67.2%) 93 (70.5%)
#> cl A.1
#> - Any Intensity - 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> MILD 30 (22.4%) 27 (20.1%) 39 (29.5%)
#> MODERATE 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd A.1.1.1.1
#> - Any Intensity - 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> MILD 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2
#> - Any Intensity - 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> MODERATE 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> - Any Intensity - 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> MILD 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> MODERATE 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd B.2.2.3.1
#> - Any Intensity - 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> MILD 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd B.2.1.2.1
#> - Any Intensity - 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> MODERATE 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> - Any Intensity - 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> MODERATE 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> SEVERE 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.1.1
#> - Any Intensity - 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> SEVERE 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2
#> - Any Intensity - 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> MODERATE 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> - Any Intensity - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> MILD 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd D.2.1.5.3
#> - Any Intensity - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> MILD 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> - Any Intensity - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> SEVERE 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd B.1.1.1.1
#> - Any Intensity - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> SEVERE 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> - Any Intensity - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> MODERATE 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.2.1.2.1
#> - Any Intensity - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> MODERATE 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> - Any Intensity - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> SEVERE 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> dcd C.1.1.1.3
#> - Any Intensity - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> SEVERE 43 (32.1%) 46 (34.3%) 43 (32.6%)
Adverse Events by Highest NCI CTCAE Grade
(AET04)
1. Adverse Events by Highest NCI CTCAE
Grade
- The
aet04template produces the standard adverse event by highestNCI CTCAEgrade summary.
- By default, this template includes the grouped grades of ‘Grade 1-2’
and ‘Grade 3-4’.
- By default this template removes the rows with 0 count.
- If a treatment group does not have any adverse event, the treatment
group is automatically displayed providing that it is defined in
ADSL.
run(aet04, syn_data)
#> MedDRA System Organ Class
#> MedDRA Preferred Term A: Drug X B: Placebo C: Combination
#> Grade (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————
#> - Any adverse events -
#> - Any Grade - 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Grade 1-2 13 (9.7%) 19 (14.2%) 11 (8.3%)
#> 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3-4 33 (24.6%) 34 (25.4%) 34 (25.8%)
#> 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> cl A.1
#> - Overall -
#> - Any Grade - 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Grade 1-2 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> 1 30 (22.4%) 27 (20.1%) 39 (29.5%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd A.1.1.1.1
#> - Any Grade - 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> Grade 1-2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2
#> - Any Grade - 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 1-2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> - Overall -
#> - Any Grade - 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Grade 1-2 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 1 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> Grade 3-4 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd B.2.2.3.1
#> - Any Grade - 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Grade 1-2 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd B.2.1.2.1
#> - Any Grade - 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Grade 3-4 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> - Overall -
#> - Any Grade - 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Grade 3-4 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> 3 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> Grade 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.1.1
#> - Any Grade - 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Grade 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2
#> - Any Grade - 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Grade 3-4 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 3 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> - Overall -
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd D.2.1.5.3
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> - Overall -
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd B.1.1.1.1
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> - Overall -
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.2.1.2.1
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> - Overall -
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 3-4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> dcd C.1.1.1.3
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 3-4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
2. Adverse Events by Highest NCI CTCAE Grade
(Fill in of Grades)
If for some preferred terms not all grades occur but all grades
should be displayed, this can be achieved by specifying
prune_0 = FALSE.
run(aet04, syn_data, prune_0 = FALSE)
#> MedDRA System Organ Class
#> MedDRA Preferred Term A: Drug X B: Placebo C: Combination
#> Grade (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————
#> - Any adverse events -
#> - Any Grade - 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Grade 1-2 13 (9.7%) 19 (14.2%) 11 (8.3%)
#> 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3-4 33 (24.6%) 34 (25.4%) 34 (25.8%)
#> 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> Grade 5 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> cl A.1
#> - Overall -
#> - Any Grade - 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Grade 1-2 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> 1 30 (22.4%) 27 (20.1%) 39 (29.5%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd A.1.1.1.1
#> - Any Grade - 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> Grade 1-2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd A.1.1.1.2
#> - Any Grade - 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 1-2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> 1 0 0 0
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> cl B.2
#> - Overall -
#> - Any Grade - 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Grade 1-2 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 1 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 2 0 0 0
#> Grade 3-4 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd B.2.2.3.1
#> - Any Grade - 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Grade 1-2 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd B.2.1.2.1
#> - Any Grade - 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 4 0 0 0
#> Grade 5 0 0 0
#> cl D.1
#> - Overall -
#> - Any Grade - 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> 3 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> 4 0 0 0
#> Grade 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.1.1
#> - Any Grade - 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2
#> - Any Grade - 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 3 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 4 0 0 0
#> Grade 5 0 0 0
#> cl D.2
#> - Overall -
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd D.2.1.5.3
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> cl B.1
#> - Overall -
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd B.1.1.1.1
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> - Overall -
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 1 0 0 0
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> dcd C.2.1.2.1
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 1 0 0 0
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 3-4 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Grade 5 0 0 0
#> cl C.1
#> - Overall -
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 3 0 0 0
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 5 0 0 0
#> dcd C.1.1.1.3
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 3 0 0 0
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 5 0 0 0
3. Adverse Events by Highest NCI CTCAE Grade
with modified grouping of grade
To collapse grade 3-4 with grade 5, this can be achieved by modifying
the definition of grade groups in grade_groups.
grade_groups <- list(
"Grade 1-2" = c("1", "2"),
"Grade 3-5" = c("3", "4", "5")
)
run(aet04, syn_data, grade_groups = grade_groups, prune_0 = FALSE)
#> MedDRA System Organ Class
#> MedDRA Preferred Term A: Drug X B: Placebo C: Combination
#> Grade (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————
#> - Any adverse events -
#> - Any Grade - 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Grade 1-2 13 (9.7%) 19 (14.2%) 11 (8.3%)
#> 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3-5 109 (81.3%) 104 (77.6%) 109 (82.6%)
#> 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> 5 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> cl A.1
#> - Overall -
#> - Any Grade - 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Grade 1-2 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> 1 30 (22.4%) 27 (20.1%) 39 (29.5%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> dcd A.1.1.1.1
#> - Any Grade - 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> Grade 1-2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 2 0 0 0
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> dcd A.1.1.1.2
#> - Any Grade - 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 1-2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> 1 0 0 0
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> cl B.2
#> - Overall -
#> - Any Grade - 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Grade 1-2 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 1 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 2 0 0 0
#> Grade 3-5 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 4 0 0 0
#> 5 0 0 0
#> dcd B.2.2.3.1
#> - Any Grade - 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Grade 1-2 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 2 0 0 0
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> dcd B.2.1.2.1
#> - Any Grade - 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 4 0 0 0
#> 5 0 0 0
#> cl D.1
#> - Overall -
#> - Any Grade - 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> 3 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> 4 0 0 0
#> 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.1.1
#> - Any Grade - 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> 3 0 0 0
#> 4 0 0 0
#> 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2
#> - Any Grade - 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 3 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 4 0 0 0
#> 5 0 0 0
#> cl D.2
#> - Overall -
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 2 0 0 0
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> dcd D.2.1.5.3
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 2 0 0 0
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> cl B.1
#> - Overall -
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> 3 0 0 0
#> 4 0 0 0
#> 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd B.1.1.1.1
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> 3 0 0 0
#> 4 0 0 0
#> 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> - Overall -
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 1 0 0 0
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> dcd C.2.1.2.1
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 1 0 0 0
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 3-5 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 5 0 0 0
#> cl C.1
#> - Overall -
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 3 0 0 0
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 5 0 0 0
#> dcd C.1.1.1.3
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 1-2 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> Grade 3-5 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 3 0 0 0
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 5 0 0 0
Most Common (>=5%) Adverse Events
(AET05)
1. Most Common (>=5%) Adverse Events
- The
aet10template produces the standard most common adverse events occurring with relative frequency >=5% output.
run(aet10, syn_data)
#> A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)2. Most Common (>=8%) Adverse Events (setting threshold)
To modify the threshold for displaying preferred terms, this can be
achieved by providing the threshold to the atleast
parameter.
run(aet10, syn_data, atleast = 0.08)
#> A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)
Concomitant Medications by Medication Class and Preferred
Name (CMT01A)
1. Concomitant Medications by Medication Class and Preferred Name
- The
cmt01atemplate displays concomitant medications byATC Level 2and Preferred Name by default.
- The template does not include the column of total by default.
- The template sort medication class and preferred name by alphabetical order by default.
run(cmt01a, syn_data)
#> ATC Level 2 Text A: Drug X B: Placebo C: Combination
#> Other Treatment (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one treatment 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of treatments 609 622 703
#> ATCCLAS2 A
#> Total number of patients with at least one treatment 97 (72.4%) 98 (73.1%) 102 (77.3%)
#> Total number of treatments 205 207 242
#> medname A_1/3 54 (40.3%) 49 (36.6%) 69 (52.3%)
#> medname A_2/3 53 (39.6%) 50 (37.3%) 56 (42.4%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS2 A p2
#> Total number of patients with at least one treatment 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> Total number of treatments 58 66 64
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS2 B
#> Total number of patients with at least one treatment 102 (76.1%) 101 (75.4%) 108 (81.8%)
#> Total number of treatments 264 275 306
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> medname B_4/4 50 (37.3%) 45 (33.6%) 55 (41.7%)
#> medname B_3/4 47 (35.1%) 47 (35.1%) 52 (39.4%)
#> ATCCLAS2 B p2
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 B p3
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 C
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 C p2
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 C p3
#> Total number of patients with at least one treatment 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> Total number of treatments 69 73 80
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
2. Concomitant Medications by Medication Class and Preferred
Name (changing ATC class level)
run(cmt01a, syn_data, row_split_var = "ATC1")
#> ATC Level 1 Text A: Drug X B: Placebo C: Combination
#> Other Treatment (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one treatment 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of treatments 609 622 703
#> ATCCLAS1 A
#> Total number of patients with at least one treatment 97 (72.4%) 98 (73.1%) 102 (77.3%)
#> Total number of treatments 205 207 242
#> medname A_1/3 54 (40.3%) 49 (36.6%) 69 (52.3%)
#> medname A_2/3 53 (39.6%) 50 (37.3%) 56 (42.4%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS1 A p2
#> Total number of patients with at least one treatment 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> Total number of treatments 58 66 64
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS1 B
#> Total number of patients with at least one treatment 102 (76.1%) 101 (75.4%) 108 (81.8%)
#> Total number of treatments 264 275 306
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> medname B_4/4 50 (37.3%) 45 (33.6%) 55 (41.7%)
#> medname B_3/4 47 (35.1%) 47 (35.1%) 52 (39.4%)
#> ATCCLAS1 B p2
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS1 B p3
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS1 C
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS1 C p2
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS1 C p3
#> Total number of patients with at least one treatment 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> Total number of treatments 69 73 80
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)3. Concomitant Medications by Medication Class and Preferred Name (classes sorted by frequency)
The option sort_by_freq = TRUE sort medication class by
frequency.
run(cmt01a, syn_data, sort_by_freq = TRUE)
#> ATC Level 2 Text A: Drug X B: Placebo C: Combination
#> Other Treatment (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one treatment 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of treatments 609 622 703
#> ATCCLAS2 B
#> Total number of patients with at least one treatment 102 (76.1%) 101 (75.4%) 108 (81.8%)
#> Total number of treatments 264 275 306
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> medname B_4/4 50 (37.3%) 45 (33.6%) 55 (41.7%)
#> medname B_3/4 47 (35.1%) 47 (35.1%) 52 (39.4%)
#> ATCCLAS2 A
#> Total number of patients with at least one treatment 97 (72.4%) 98 (73.1%) 102 (77.3%)
#> Total number of treatments 205 207 242
#> medname A_1/3 54 (40.3%) 49 (36.6%) 69 (52.3%)
#> medname A_2/3 53 (39.6%) 50 (37.3%) 56 (42.4%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS2 C
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 C p2
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> Total number of treatments 140 140 155
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 B p2
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 B p3
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> Total number of treatments 139 155 159
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 C p3
#> Total number of patients with at least one treatment 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> Total number of treatments 69 73 80
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> ATCCLAS2 A p2
#> Total number of patients with at least one treatment 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> Total number of treatments 58 66 64
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)4. Concomitant Medications by Medication Class and Preferred Name (total number of treatments per medication class suppressed)
The cmt01a template includes the
analysis of ‘total number of treatments’ by default, modify
summary_labels to change it.
run(cmt01a, syn_data, summary_labels = list(TOTAL = cmt01_label, ATC2 = cmt01_label[1]))
#> ATC Level 2 Text A: Drug X B: Placebo C: Combination
#> Other Treatment (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one treatment 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of treatments 609 622 703
#> ATCCLAS2 A
#> Total number of patients with at least one treatment 97 (72.4%) 98 (73.1%) 102 (77.3%)
#> medname A_1/3 54 (40.3%) 49 (36.6%) 69 (52.3%)
#> medname A_2/3 53 (39.6%) 50 (37.3%) 56 (42.4%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS2 A p2
#> Total number of patients with at least one treatment 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> ATCCLAS2 B
#> Total number of patients with at least one treatment 102 (76.1%) 101 (75.4%) 108 (81.8%)
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> medname B_4/4 50 (37.3%) 45 (33.6%) 55 (41.7%)
#> medname B_3/4 47 (35.1%) 47 (35.1%) 52 (39.4%)
#> ATCCLAS2 B p2
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 B p3
#> Total number of patients with at least one treatment 78 (58.2%) 82 (61.2%) 89 (67.4%)
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> ATCCLAS2 C
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 C p2
#> Total number of patients with at least one treatment 82 (61.2%) 84 (62.7%) 89 (67.4%)
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> ATCCLAS2 C p3
#> Total number of patients with at least one treatment 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
Concomitant Medications by Preferred Name
(CMT02_PT)
1. Concomitant Medications by Preferred Name
- The
cmt02_pttemplate displays concomitant medications by Preferred Name by default.
- The template does not include the column of total by default.
- The template sorts preferred name by alphabetical order by default.
Set the option
sort_by_freq = TRUEto sort preferred names by frequency.
run(cmt02_pt, syn_data)
#> Other Treatment A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one treatment 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of treatments 609 622 703
#> medname A_1/3 54 (40.3%) 49 (36.6%) 69 (52.3%)
#> medname C_2/2 52 (38.8%) 58 (43.3%) 60 (45.5%)
#> medname B_1/4 52 (38.8%) 57 (42.5%) 59 (44.7%)
#> medname B_2/4 52 (38.8%) 55 (41.0%) 56 (42.4%)
#> medname A_2/3 53 (39.6%) 50 (37.3%) 56 (42.4%)
#> medname C_1/2 51 (38.1%) 50 (37.3%) 56 (42.4%)
#> medname B_4/4 50 (37.3%) 45 (33.6%) 55 (41.7%)
#> medname A_3/3 45 (33.6%) 54 (40.3%) 48 (36.4%)
#> medname B_3/4 47 (35.1%) 47 (35.1%) 52 (39.4%)
Demographics and Baseline Characteristics
(DMT01)
1. Demographics and Baseline Characteristics with All Patients
- The
dmt01template produces the standard demographics and baseline characteristics summary.
- This template includes the column of total by default.
run(dmt01, syn_data)
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> ——————————————————————————————————————————————————————————————————————————————————————————————
#> Age (yr)
#> n 134 134 132 400
#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7) 34.9 (7.4)
#> Median 33.0 35.0 35.0 34.0
#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0 20.0 - 69.0
#> Age Group
#> n 134 134 132 400
#> <65 134 (100%) 134 (100%) 131 (99.2%) 399 (99.8%)
#> >=65 0 0 1 (0.8%) 1 (0.2%)
#> Sex
#> n 134 134 132 400
#> Male 55 (41.0%) 52 (38.8%) 62 (47.0%) 169 (42.2%)
#> Female 79 (59.0%) 82 (61.2%) 70 (53.0%) 231 (57.8%)
#> Ethnicity
#> n 134 134 132 400
#> NOT REPORTED 6 (4.5%) 10 (7.5%) 11 (8.3%) 27 (6.8%)
#> HISPANIC OR LATINO 15 (11.2%) 18 (13.4%) 15 (11.4%) 48 (12.0%)
#> NOT HISPANIC OR LATINO 104 (77.6%) 103 (76.9%) 101 (76.5%) 308 (77.0%)
#> UNKNOWN 9 (6.7%) 3 (2.2%) 5 (3.8%) 17 (4.2%)
#> RACE
#> n 134 134 132 400
#> AMERICAN INDIAN OR ALASKA NATIVE 8 (6.0%) 11 (8.2%) 6 (4.5%) 25 (6.2%)
#> ASIAN 68 (50.7%) 68 (50.7%) 73 (55.3%) 209 (52.2%)
#> BLACK OR AFRICAN AMERICAN 31 (23.1%) 28 (20.9%) 32 (24.2%) 91 (22.8%)
#> WHITE 27 (20.1%) 27 (20.1%) 21 (15.9%) 75 (18.8%)2. Demographics and Baseline Characteristics without All Patients
To remove the column of total, set the parameter
lbl_overall to NULL.
run(dmt01, syn_data, lbl_overall = NULL)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————
#> Age (yr)
#> n 134 134 132
#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7)
#> Median 33.0 35.0 35.0
#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0
#> Age Group
#> n 134 134 132
#> <65 134 (100%) 134 (100%) 131 (99.2%)
#> >=65 0 0 1 (0.8%)
#> Sex
#> n 134 134 132
#> Male 55 (41.0%) 52 (38.8%) 62 (47.0%)
#> Female 79 (59.0%) 82 (61.2%) 70 (53.0%)
#> Ethnicity
#> n 134 134 132
#> NOT REPORTED 6 (4.5%) 10 (7.5%) 11 (8.3%)
#> HISPANIC OR LATINO 15 (11.2%) 18 (13.4%) 15 (11.4%)
#> NOT HISPANIC OR LATINO 104 (77.6%) 103 (76.9%) 101 (76.5%)
#> UNKNOWN 9 (6.7%) 3 (2.2%) 5 (3.8%)
#> RACE
#> n 134 134 132
#> AMERICAN INDIAN OR ALASKA NATIVE 8 (6.0%) 11 (8.2%) 6 (4.5%)
#> ASIAN 68 (50.7%) 68 (50.7%) 73 (55.3%)
#> BLACK OR AFRICAN AMERICAN 31 (23.1%) 28 (20.9%) 32 (24.2%)
#> WHITE 27 (20.1%) 27 (20.1%) 21 (15.9%)3. Demographics and Baseline Characteristics with an additional study specific continuous variable
- Study specific continuous variables can be added to the standard
demographics and baseline characteristics summary by editing the
parameter
summaryvars. To add or remove analyses, you need to list all variables you would like to include in the parameter.
- CHEVRON performs the analysis based on the type of variable as defined in the input data.
run(dmt01, syn_data, summaryvars = c("AGE", "AGEGR1", "SEX", "ETHNIC", "RACE", "BBMISI"), lbl_overall = NULL)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————
#> Age
#> n 134 134 132
#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7)
#> Median 33.0 35.0 35.0
#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0
#> Age Group
#> n 134 134 132
#> <65 134 (100%) 134 (100%) 131 (99.2%)
#> >=65 0 0 1 (0.8%)
#> Sex
#> n 134 134 132
#> Male 55 (41.0%) 52 (38.8%) 62 (47.0%)
#> Female 79 (59.0%) 82 (61.2%) 70 (53.0%)
#> Ethnicity
#> n 134 134 132
#> NOT REPORTED 6 (4.5%) 10 (7.5%) 11 (8.3%)
#> HISPANIC OR LATINO 15 (11.2%) 18 (13.4%) 15 (11.4%)
#> NOT HISPANIC OR LATINO 104 (77.6%) 103 (76.9%) 101 (76.5%)
#> UNKNOWN 9 (6.7%) 3 (2.2%) 5 (3.8%)
#> RACE
#> n 134 134 132
#> AMERICAN INDIAN OR ALASKA NATIVE 8 (6.0%) 11 (8.2%) 6 (4.5%)
#> ASIAN 68 (50.7%) 68 (50.7%) 73 (55.3%)
#> BLACK OR AFRICAN AMERICAN 31 (23.1%) 28 (20.9%) 32 (24.2%)
#> WHITE 27 (20.1%) 27 (20.1%) 21 (15.9%)
#> Baseline BMI
#> n 134 134 132
#> Mean (SD) 30.0 (18.3) 32.4 (23.2) 30.1 (18.4)
#> Median 27.1 31.1 30.0
#> Min - Max -6.9 - 75.9 -26.6 - 117.9 -44.2 - 87.54. Demographics and Baseline Characteristics with an additional study specific categorical variable
- Study specific categorical variables can be added to the standard
demographics and baseline characteristics summary by editing the
parameter
summaryvars.
- To display the values within a categorical variable in pre-specified order, the categorical variable need to be factorized with pre-specified order provided as levels.
proc_data <- syn_data
proc_data$adsl <- proc_data$adsl %>%
mutate(
SEX = reformat(.data$SEX, rule(Male = "M", Female = "F")),
BBMIGR1 = factor(case_when(
BBMISI < 15 ~ "Very severely underweight",
BBMISI >= 15 & BBMISI < 16 ~ "Severely underweight",
BBMISI >= 16 & BBMISI < 18.5 ~ "Underweight",
BBMISI >= 18.5 & BBMISI < 25 ~ "Normal (healthy weight)",
BBMISI >= 25 & BBMISI < 30 ~ "Overweight",
BBMISI >= 30 & BBMISI < 35 ~ "Obese Class I (Moderately obese)",
BBMISI >= 35 & BBMISI < 40 ~ "Obese Class II (Severely obese)",
BBMISI >= 40 ~ "Obese Class III (Very severely obese)"
), levels = c(
"Very severely underweight",
"Severely underweight",
"Underweight",
"Normal (healthy weight)",
"Overweight",
"Obese Class I (Moderately obese)",
"Obese Class II (Severely obese)",
"Obese Class III (Very severely obese)"
))
)
run(dmt01, proc_data, summaryvars = c("AGE", "AGEGR1", "SEX", "ETHNIC", "RACE", "BBMIGR1"), auto_pre = FALSE)
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Age
#> n 134 134 132 400
#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7) 34.9 (7.4)
#> Median 33.0 35.0 35.0 34.0
#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0 20.0 - 69.0
#> Age Group
#> n 134 134 132 400
#> <65 134 (100%) 134 (100%) 131 (99.2%) 399 (99.8%)
#> >=65 0 0 1 (0.8%) 1 (0.2%)
#> Sex
#> n 134 134 132 400
#> Male 55 (41.0%) 52 (38.8%) 62 (47.0%) 169 (42.2%)
#> Female 79 (59.0%) 82 (61.2%) 70 (53.0%) 231 (57.8%)
#> Ethnicity
#> n 134 134 132 400
#> NOT REPORTED 6 (4.5%) 10 (7.5%) 11 (8.3%) 27 (6.8%)
#> HISPANIC OR LATINO 15 (11.2%) 18 (13.4%) 15 (11.4%) 48 (12.0%)
#> NOT HISPANIC OR LATINO 104 (77.6%) 103 (76.9%) 101 (76.5%) 308 (77.0%)
#> UNKNOWN 9 (6.7%) 3 (2.2%) 5 (3.8%) 17 (4.2%)
#> RACE
#> n 134 134 132 400
#> AMERICAN INDIAN OR ALASKA NATIVE 8 (6.0%) 11 (8.2%) 6 (4.5%) 25 (6.2%)
#> ASIAN 68 (50.7%) 68 (50.7%) 73 (55.3%) 209 (52.2%)
#> BLACK OR AFRICAN AMERICAN 31 (23.1%) 28 (20.9%) 32 (24.2%) 91 (22.8%)
#> WHITE 27 (20.1%) 27 (20.1%) 21 (15.9%) 75 (18.8%)
#> BBMIGR1
#> n 134 134 132 400
#> Very severely underweight 31 (23.1%) 29 (21.6%) 24 (18.2%) 84 (21.0%)
#> Severely underweight 4 (3.0%) 1 (0.7%) 1 (0.8%) 6 (1.5%)
#> Underweight 9 (6.7%) 7 (5.2%) 3 (2.3%) 19 (4.8%)
#> Normal (healthy weight) 17 (12.7%) 18 (13.4%) 20 (15.2%) 55 (13.8%)
#> Overweight 11 (8.2%) 10 (7.5%) 18 (13.6%) 39 (9.8%)
#> Obese Class I (Moderately obese) 12 (9.0%) 11 (8.2%) 16 (12.1%) 39 (9.8%)
#> Obese Class II (Severely obese) 11 (8.2%) 13 (9.7%) 16 (12.1%) 40 (10.0%)
#> Obese Class III (Very severely obese) 39 (29.1%) 45 (33.6%) 34 (25.8%) 118 (29.5%)
5. Demographics and Baseline Characteristics with additional
vital signs baseline values from ADVS or
ADSUB
To add baseline vital signs or other baseline characteristics to the
demographics and baseline characteristics summary, manual preprocess of
input adsl dataset is expected and merge the vital signs
baseline values from advs (where
ADVS.ABLFL == "Y") or adsub with
adsl by unique subject identifier.
proc_data <- syn_data
diabpbl <- proc_data$advs %>%
filter(ABLFL == "Y" & PARAMCD == "DIABP") %>%
mutate(DIABPBL = AVAL) %>%
select("STUDYID", "USUBJID", "DIABPBL")
proc_data$adsl <- proc_data$adsl %>%
mutate(SEX = reformat(.data$SEX, rule(Male = "M", Female = "F"))) %>%
left_join(diabpbl, by = c("STUDYID", "USUBJID"))
run(dmt01, proc_data, summaryvars = c("AGE", "AGEGR1", "SEX", "ETHNIC", "RACE", "DIABPBL"), auto_pre = FALSE)
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> ——————————————————————————————————————————————————————————————————————————————————————————————
#> Age
#> n 134 134 132 400
#> Mean (SD) 33.8 (6.6) 35.4 (7.9) 35.4 (7.7) 34.9 (7.4)
#> Median 33.0 35.0 35.0 34.0
#> Min - Max 21.0 - 50.0 21.0 - 62.0 20.0 - 69.0 20.0 - 69.0
#> Age Group
#> n 134 134 132 400
#> <65 134 (100%) 134 (100%) 131 (99.2%) 399 (99.8%)
#> >=65 0 0 1 (0.8%) 1 (0.2%)
#> Sex
#> n 134 134 132 400
#> Male 55 (41.0%) 52 (38.8%) 62 (47.0%) 169 (42.2%)
#> Female 79 (59.0%) 82 (61.2%) 70 (53.0%) 231 (57.8%)
#> Ethnicity
#> n 134 134 132 400
#> NOT REPORTED 6 (4.5%) 10 (7.5%) 11 (8.3%) 27 (6.8%)
#> HISPANIC OR LATINO 15 (11.2%) 18 (13.4%) 15 (11.4%) 48 (12.0%)
#> NOT HISPANIC OR LATINO 104 (77.6%) 103 (76.9%) 101 (76.5%) 308 (77.0%)
#> UNKNOWN 9 (6.7%) 3 (2.2%) 5 (3.8%) 17 (4.2%)
#> RACE
#> n 134 134 132 400
#> AMERICAN INDIAN OR ALASKA NATIVE 8 (6.0%) 11 (8.2%) 6 (4.5%) 25 (6.2%)
#> ASIAN 68 (50.7%) 68 (50.7%) 73 (55.3%) 209 (52.2%)
#> BLACK OR AFRICAN AMERICAN 31 (23.1%) 28 (20.9%) 32 (24.2%) 91 (22.8%)
#> WHITE 27 (20.1%) 27 (20.1%) 21 (15.9%) 75 (18.8%)
#> Analysis Value
#> n 134 134 132 400
#> Mean (SD) 48.6 (8.0) 50.4 (7.9) 51.1 (7.8) 50.0 (8.0)
#> Median 48.4 50.2 50.8 50.0
#> Min - Max 27.7 - 64.6 21.7 - 67.5 29.7 - 71.4 21.7 - 71.4
Patient Disposition (DST01)
1. Patient Disposition
- The
dst01template produces the standard patient disposition summary.
- The template includes the column of total by default. Use
lbl_overall = NULLto suppress the default.
run(dst01, syn_data, lbl_overall = NULL)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————
#> Completed 68 (50.7%) 66 (49.3%) 73 (55.3%)
#> Ongoing 24 (17.9%) 28 (20.9%) 21 (15.9%)
#> Discontinued 42 (31.3%) 40 (29.9%) 38 (28.8%)
#> ADVERSE EVENT 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> DEATH 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> LACK OF EFFICACY 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> PHYSICIAN DECISION 2 (1.5%) 3 (2.2%) 2 (1.5%)
#> PROTOCOL VIOLATION 5 (3.7%) 3 (2.2%) 4 (3.0%)
#> WITHDRAWAL BY PARENT/GUARDIAN 4 (3.0%) 2 (1.5%) 1 (0.8%)
#> WITHDRAWAL BY SUBJECT 1 (0.7%) 1 (0.7%) 1 (0.8%)2. Patient Disposition (with grouping of reasons)
- The syntax below produces the standard patient disposition summary
with grouping of the discontinuation reasons.
- The variable [
ADSL.DCSREASGP] that groups the discontinuation reasons needs to be derived manually and provided in the inputadsldataset.
run(dst01, syn_data, detail_vars = list(Discontinued = c("DCSREASGP", "DCSREAS")), lbl_overall = NULL)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————
#> Completed 68 (50.7%) 66 (49.3%) 73 (55.3%)
#> Ongoing 24 (17.9%) 28 (20.9%) 21 (15.9%)
#> Discontinued 42 (31.3%) 40 (29.9%) 38 (28.8%)
#> Safety
#> ADVERSE EVENT 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> DEATH 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> Non-Safety
#> LACK OF EFFICACY 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> PHYSICIAN DECISION 2 (1.5%) 3 (2.2%) 2 (1.5%)
#> PROTOCOL VIOLATION 5 (3.7%) 3 (2.2%) 4 (3.0%)
#> WITHDRAWAL BY PARENT/GUARDIAN 4 (3.0%) 2 (1.5%) 1 (0.8%)
#> WITHDRAWAL BY SUBJECT 1 (0.7%) 1 (0.7%) 1 (0.8%)3. Patient Disposition (adding end of treatment status)
The syntax below adds the end of treatment status to the standard
patient disposition summary by providing the end of treatment status
variable to the parameter trt_status_var.
run(dst01, syn_data, trt_status_var = "EOTSTT", lbl_overall = NULL)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————
#> Completed 68 (50.7%) 66 (49.3%) 73 (55.3%)
#> Ongoing 24 (17.9%) 28 (20.9%) 21 (15.9%)
#> Discontinued 42 (31.3%) 40 (29.9%) 38 (28.8%)
#> ADVERSE EVENT 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> DEATH 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> LACK OF EFFICACY 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> PHYSICIAN DECISION 2 (1.5%) 3 (2.2%) 2 (1.5%)
#> PROTOCOL VIOLATION 5 (3.7%) 3 (2.2%) 4 (3.0%)
#> WITHDRAWAL BY PARENT/GUARDIAN 4 (3.0%) 2 (1.5%) 1 (0.8%)
#> WITHDRAWAL BY SUBJECT 1 (0.7%) 1 (0.7%) 1 (0.8%)
#> Completed Treatment 47 (35.1%) 35 (26.1%) 42 (31.8%)
#> Ongoing Treatment 39 (29.1%) 46 (34.3%) 46 (34.8%)
#> Discontinued Treatment 48 (35.8%) 53 (39.6%) 44 (33.3%)4. Patient Disposition (adding details of study ongoing status)
The syntax adds the details of study ongoing/alive status to the
standard patient disposition summary by modifying the parameter
detail_vars.
run(dst01, syn_data, detail_vars = list(Discontinued = "DCSREAS", Ongoing = "STDONS"))
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> —————————————————————————————————————————————————————————————————————————————————————————
#> Completed 68 (50.7%) 66 (49.3%) 73 (55.3%) 207 (51.7%)
#> Ongoing 24 (17.9%) 28 (20.9%) 21 (15.9%) 73 (18.2%)
#> Alive: Ongoing 8 (6.0%) 6 (4.5%) 8 (6.1%) 22 (5.5%)
#> Alive: In Follow-up 16 (11.9%) 22 (16.4%) 13 (9.8%) 51 (12.8%)
#> Discontinued 42 (31.3%) 40 (29.9%) 38 (28.8%) 120 (30.0%)
#> ADVERSE EVENT 3 (2.2%) 6 (4.5%) 5 (3.8%) 14 (3.5%)
#> DEATH 25 (18.7%) 23 (17.2%) 22 (16.7%) 70 (17.5%)
#> LACK OF EFFICACY 2 (1.5%) 2 (1.5%) 3 (2.3%) 7 (1.8%)
#> PHYSICIAN DECISION 2 (1.5%) 3 (2.2%) 2 (1.5%) 7 (1.8%)
#> PROTOCOL VIOLATION 5 (3.7%) 3 (2.2%) 4 (3.0%) 12 (3.0%)
#> WITHDRAWAL BY PARENT/GUARDIAN 4 (3.0%) 2 (1.5%) 1 (0.8%) 7 (1.8%)
#> WITHDRAWAL BY SUBJECT 1 (0.7%) 1 (0.7%) 1 (0.8%) 3 (0.8%)
Deaths (DTHT01)
1. Deaths
The dtht01 template produces the
standard deaths output.
run(dst01, syn_data)
#> A: Drug X B: Placebo C: Combination All Patients
#> (N=134) (N=134) (N=132) (N=400)
#> —————————————————————————————————————————————————————————————————————————————————————————
#> Completed 68 (50.7%) 66 (49.3%) 73 (55.3%) 207 (51.7%)
#> Ongoing 24 (17.9%) 28 (20.9%) 21 (15.9%) 73 (18.2%)
#> Discontinued 42 (31.3%) 40 (29.9%) 38 (28.8%) 120 (30.0%)
#> ADVERSE EVENT 3 (2.2%) 6 (4.5%) 5 (3.8%) 14 (3.5%)
#> DEATH 25 (18.7%) 23 (17.2%) 22 (16.7%) 70 (17.5%)
#> LACK OF EFFICACY 2 (1.5%) 2 (1.5%) 3 (2.3%) 7 (1.8%)
#> PHYSICIAN DECISION 2 (1.5%) 3 (2.2%) 2 (1.5%) 7 (1.8%)
#> PROTOCOL VIOLATION 5 (3.7%) 3 (2.2%) 4 (3.0%) 12 (3.0%)
#> WITHDRAWAL BY PARENT/GUARDIAN 4 (3.0%) 2 (1.5%) 1 (0.8%) 7 (1.8%)
#> WITHDRAWAL BY SUBJECT 1 (0.7%) 1 (0.7%) 1 (0.8%) 3 (0.8%)2. Deaths (adding “Primary Cause of Death” details for ‘Other’ category)
run(dtht01, syn_data, other_category = TRUE)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————
#> Total number of deaths 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> Primary Cause of Death
#> n 25 23 22
#> Adverse Event 9 (36.0%) 7 (30.4%) 10 (45.5%)
#> Progressive Disease 8 (32.0%) 6 (26.1%) 6 (27.3%)
#> Other 8 (32.0%) 10 (43.5%) 6 (27.3%)
#> LOST TO FOLLOW UP 2 (8.3%) 2 (8.3%) 2 (8.3%)
#> MISSING 2 (8.3%) 3 (12.5%) 2 (8.3%)
#> Post-study reporting of death 1 (4.2%) 2 (8.3%) 1 (4.2%)
#> SUICIDE 2 (8.3%) 2 (8.3%) 1 (4.2%)
#> UNKNOWN 1 (4.2%) 1 (4.2%) 0NOTE: In order to avoid the warning above and display ‘Other’ as the
last category under “Primary Cause of Death” right above the detailed
reasons for “Other”, the user is expected to manually provide levels to
ADSL.DTHCAT based on categories available in the
dataset.
3. Deaths (adding summary by days from last study drug administration)
Setting time_since_last_dose to TRUE, the
syntax produces the count of deaths by days from last study drug
administration as well as the count of deaths by primary cause and days
from last study drug administration.
run(dtht01, syn_data, time_since_last_dose = TRUE)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of deaths 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> Days from last drug administration
#> n 25 23 22
#> <=30 14 (56.0%) 11 (47.8%) 14 (63.6%)
#> >30 11 (44.0%) 12 (52.2%) 8 (36.4%)
#> Primary cause by days from last study drug administration
#> <=30
#> n 14 11 14
#> Adverse Event 4 (28.6%) 2 (18.2%) 6 (42.9%)
#> Progressive Disease 6 (42.9%) 3 (27.3%) 4 (28.6%)
#> Other 4 (28.6%) 6 (54.5%) 4 (28.6%)
#> >30
#> n 11 12 8
#> Adverse Event 5 (45.5%) 5 (41.7%) 4 (50.0%)
#> Progressive Disease 2 (18.2%) 3 (25.0%) 2 (25.0%)
#> Other 4 (36.4%) 4 (33.3%) 2 (25.0%)
ECG Results and Change from Baseline by Visit
(EGT01)
1. ECG Results and Change from Baseline by Visit
The egt01 template produces the
standard ECG results and change from baseline by visit summary.
run(egt01, syn_data)
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Change from Change from Change from
#> Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline
#> (N=134) (N=134) (N=134) (N=134) (N=132) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 134 132
#> Mean (SD) 71.447 (17.932) 69.829 (20.717) 69.341 (20.948)
#> Median 72.697 73.352 71.956
#> Min - Max 9.09 - 106.91 13.49 - 115.52 11.63 - 115.49
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 70.191 (20.274) -1.257 (25.966) 69.427 (20.799) -0.401 (29.735) 68.654 (18.064) -0.687 (27.807)
#> Median 70.703 -2.197 70.462 -0.520 68.573 -0.760
#> Min - Max 8.53 - 127.50 -50.97 - 89.16 16.85 - 129.14 -68.18 - 88.38 16.87 - 115.60 -68.25 - 67.20
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 70.317 (19.561) -1.130 (26.262) 71.108 (20.556) 1.279 (31.353) 69.193 (18.056) -0.148 (28.606)
#> Median 70.885 -1.105 72.524 -0.311 69.304 -1.548
#> Min - Max 17.14 - 116.32 -85.03 - 67.52 9.22 - 120.54 -73.07 - 81.44 29.62 - 120.50 -67.75 - 66.29
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 68.251 (20.168) -3.196 (28.657) 68.947 (20.558) -0.881 (30.142) 70.884 (20.280) 1.543 (27.285)
#> Median 68.787 -2.167 67.802 1.195 70.124 0.139
#> Min - Max 13.33 - 131.73 -81.20 - 72.57 23.98 - 130.41 -73.03 - 103.31 20.91 - 116.79 -64.51 - 72.52
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 70.063 (18.410) -1.385 (26.595) 71.601 (20.336) 1.772 (30.262) 71.020 (20.591) 1.679 (29.597)
#> Median 69.330 -4.535 72.211 -0.884 70.523 3.811
#> Min - Max 22.30 - 116.51 -58.07 - 77.32 17.53 - 129.06 -64.32 - 85.34 10.35 - 117.30 -65.91 - 105.67
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 66.406 (19.745) -5.041 (27.112) 71.252 (18.923) 1.423 (27.084) 71.257 (18.563) 1.916 (29.591)
#> Median 65.405 -6.827 70.858 0.637 73.292 1.735
#> Min - Max 23.89 - 110.38 -73.26 - 57.24 25.86 - 125.73 -71.15 - 67.37 23.89 - 117.19 -58.23 - 68.86
#> QT Duration
#> BASELINE
#> n 134 134 132
#> Mean (SD) 336.834 (117.958) 351.004 (98.436) 352.598 (105.114)
#> Median 344.414 351.480 347.956
#> Min - Max 86.98 - 665.40 98.90 - 641.92 105.68 - 628.14
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 342.574 (101.093) 5.741 (159.936) 363.946 (102.338) 12.943 (140.729) 359.424 (105.161) 6.826 (147.129)
#> Median 347.264 -1.779 356.539 13.730 363.838 8.685
#> Min - Max 91.63 - 591.42 -346.44 - 452.75 114.92 - 656.45 -317.53 - 416.35 51.91 - 611.88 -473.19 - 358.00
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 353.244 (93.926) 16.410 (162.103) 345.926 (96.783) -5.078 (152.509) 335.689 (98.605) -16.909 (138.448)
#> Median 351.099 16.722 346.831 -9.681 320.957 -22.267
#> Min - Max 138.01 - 587.30 -414.07 - 389.16 146.42 - 556.07 -440.28 - 364.76 104.91 - 562.34 -326.55 - 325.27
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 370.115 (101.568) 33.282 (152.780) 343.412 (102.585) -7.592 (138.803) 346.947 (94.965) -5.652 (144.651)
#> Median 378.209 39.586 335.119 -15.888 352.154 9.113
#> Min - Max 118.14 - 615.18 -391.72 - 520.09 63.37 - 566.51 -311.28 - 293.76 126.09 - 580.81 -412.11 - 410.01
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 345.774 (95.970) 8.941 (145.647) 354.377 (108.286) 3.374 (142.390) 341.358 (106.745) -11.240 (145.648)
#> Median 340.134 5.576 346.699 -17.129 352.295 -11.868
#> Min - Max 110.12 - 616.58 -393.34 - 456.04 80.82 - 687.69 -439.90 - 364.80 4.95 - 570.61 -480.94 - 330.67
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 358.903 (97.693) 22.069 (155.681) 338.648 (99.260) -12.356 (130.457) 349.303 (95.769) -3.296 (135.997)
#> Median 351.959 5.886 344.167 0.405 350.319 12.680
#> Min - Max 88.38 - 661.12 -353.30 - 539.84 31.25 - 563.90 -338.85 - 352.75 119.02 - 581.83 -311.45 - 295.53
#> RR Duration
#> BASELINE
#> n 134 134 132
#> Mean (SD) 1028.419 (286.385) 1027.484 (324.000) 1074.623 (277.328)
#> Median 1041.860 1047.268 1080.866
#> Min - Max 34.33 - 1783.71 5.29 - 1877.19 289.60 - 1617.06
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 990.155 (318.736) -38.264 (446.403) 1061.587 (269.138) 34.103 (401.759) 1039.642 (284.389) -34.981 (406.037)
#> Median 963.881 -86.501 1061.504 66.914 1014.780 -97.826
#> Min - Max 110.82 - 2014.56 -1014.82 - 1389.40 276.83 - 1711.99 -942.16 - 993.82 498.21 - 1937.47 -958.61 - 908.90
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.371 (304.135) -15.047 (425.807) 1109.402 (318.227) 81.918 (453.105) 1045.209 (277.506) -29.414 (380.841)
#> Median 1040.693 40.485 1117.764 69.275 1034.637 -15.331
#> Min - Max 164.19 - 1677.10 -1216.10 - 1053.15 160.73 - 2048.73 -1127.10 - 1148.61 252.84 - 1722.33 -859.27 - 871.54
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.987 (304.990) -14.431 (406.529) 1118.345 (296.527) 90.861 (409.573) 1036.593 (268.521) -38.030 (421.484)
#> Median 1027.232 -50.543 1134.596 52.029 1030.717 -60.720
#> Min - Max 357.04 - 1798.65 -882.94 - 1080.26 97.14 - 1825.43 -887.06 - 1166.15 446.02 - 1713.38 -984.79 - 902.37
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1033.309 (313.919) 4.890 (483.153) 1079.762 (298.940) 52.278 (429.253) 1027.549 (295.856) -47.074 (378.235)
#> Median 1050.399 5.601 1051.613 69.554 1023.360 -49.519
#> Min - Max 54.33 - 1979.43 -1345.93 - 1195.41 347.94 - 1762.04 -826.43 - 1191.83 341.62 - 2144.86 -1002.03 - 1048.66
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 1072.335 (282.901) 43.916 (379.048) 1058.452 (271.012) 30.968 (436.030) 1029.043 (271.211) -45.580 (405.528)
#> Median 1067.330 55.872 1068.950 33.615 1065.256 -34.395
#> Min - Max 352.97 - 2000.56 -1028.79 - 1418.57 208.83 - 1794.73 -978.97 - 1365.13 436.28 - 1794.07 -962.18 - 1329.88
ECG Abnormalities (Regardless of Abnormality at Baseline)
(EGT02_1)
1. ECG Abnormalities (Regardless of Abnormality at Baseline)
The egt02_1 template produces the
standard ECG abnormalities summary where the abnormalities are
summarized regardless of the abnormality at baseline.
run(egt02_1, syn_data)
#> Assessment A: Drug X B: Placebo C: Combination
#> Abnormality (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————
#> Heart Rate
#> Low 49/134 (36.6%) 57/134 (42.5%) 55/132 (41.7%)
#> High 48/134 (35.8%) 51/134 (38.1%) 48/132 (36.4%)
#> QT Duration
#> Low 53/134 (39.6%) 56/134 (41.8%) 54/132 (40.9%)
#> High 45/134 (33.6%) 51/134 (38.1%) 45/132 (34.1%)
#> RR Duration
#> Low 56/134 (41.8%) 41/134 (30.6%) 50/132 (37.9%)
#> High 39/134 (29.1%) 62/134 (46.3%) 41/132 (31.1%)
ECG Abnormalities (Among Subject Without Abnormality at
Baseline) (EGT02_2)
1. ECG Abnormalities (Among Subject Without Abnormality at Baseline)
The egt02_2 template produces the
standard ECG abnormalities summary where the abnormalities are
summarized among subject without abnormality at baseline.
run(egt02_2, syn_data)
#> Assessment A: Drug X B: Placebo C: Combination
#> Abnormality (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————
#> Heart Rate
#> Low 43/128 (33.6%) 47/124 (37.9%) 40/117 (34.2%)
#> High 41/127 (32.3%) 46/129 (35.7%) 38/122 (31.1%)
#> QT Duration
#> Low 32/113 (28.3%) 48/126 (38.1%) 46/124 (37.1%)
#> High 36/125 (28.8%) 47/130 (36.2%) 33/119 (27.7%)
#> RR Duration
#> Low 51/129 (39.5%) 30/123 (24.4%) 44/126 (34.9%)
#> High 32/127 (25.2%) 50/122 (41%) 34/125 (27.2%)
Shift Table of ECG Interval Data - Baseline versus
Minimum/Maximum Post-Baseline (EGT03)
1. Shift Table of ECG Interval Data - Baseline versus Minimum Post-Baseline
The egt03 template produces the
standard shift table of ECG interval data - baseline versus minimum
post-baseline summary.
proc_data <- log_filter(syn_data, PARAMCD == "HR", "adeg")
run(egt03, proc_data)
#> Actual Arm Code Minimum Post-Baseline Assessment
#> Baseline Reference Range Indicator LOW NORMAL HIGH Missing
#> ————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> ARM A (N=134)
#> LOW 1 (0.7%) 5 (3.7%) 0 0
#> NORMAL 36 (26.9%) 85 (63.4%) 0 0
#> HIGH 3 (2.2%) 4 (3%) 0 0
#> Missing 0 0 0 0
#> ARM B (N=134)
#> LOW 1 (0.7%) 9 (6.7%) 0 0
#> NORMAL 41 (30.6%) 78 (58.2%) 0 0
#> HIGH 1 (0.7%) 4 (3%) 0 0
#> Missing 0 0 0 0
#> ARM C (N=132)
#> LOW 4 (3%) 11 (8.3%) 0 0
#> NORMAL 32 (24.2%) 75 (56.8%) 0 0
#> HIGH 1 (0.8%) 9 (6.8%) 0 0
#> Missing 0 0 0 0
ECG Actual Values and Changes from Baseline by Visit
(EGT05_QTCAT)
1. ECG Actual Values and Changes from Baseline by Visit
The egt05_qtcat template produces the
standard ECG actual values and changes from baseline by visit
summary.
run(egt05_qtcat, syn_data)
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Category (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————
#> QT Duration
#> BASELINE
#> Value at Visit
#> n 134 134 132
#> <=450 msec 115 (85.8%) 117 (87.3%) 104 (78.8%)
#> >450 to <=480 msec 6 (4.5%) 10 (7.5%) 9 (6.8%)
#> >480 to <=500 msec 4 (3.0%) 3 (2.2%) 6 (4.5%)
#> >500 msec 9 (6.7%) 4 (3.0%) 13 (9.8%)
#> WEEK 1 DAY 8
#> Value at Visit
#> n 134 134 132
#> <=450 msec 113 (84.3%) 106 (79.1%) 106 (80.3%)
#> >450 to <=480 msec 10 (7.5%) 10 (7.5%) 11 (8.3%)
#> >480 to <=500 msec 4 (3.0%) 4 (3.0%) 3 (2.3%)
#> >500 msec 7 (5.2%) 14 (10.4%) 12 (9.1%)
#> Change from Baseline
#> n 134 134 132
#> <=30 msec 76 (56.7%) 75 (56.0%) 75 (56.8%)
#> >30 to <=60 msec 7 (5.2%) 13 (9.7%) 11 (8.3%)
#> >60 msec 51 (38.1%) 46 (34.3%) 46 (34.8%)
#> WEEK 2 DAY 15
#> Value at Visit
#> n 134 134 132
#> <=450 msec 111 (82.8%) 114 (85.1%) 112 (84.8%)
#> >450 to <=480 msec 10 (7.5%) 9 (6.7%) 9 (6.8%)
#> >480 to <=500 msec 7 (5.2%) 2 (1.5%) 5 (3.8%)
#> >500 msec 6 (4.5%) 9 (6.7%) 6 (4.5%)
#> Change from Baseline
#> n 134 134 132
#> <=30 msec 71 (53.0%) 87 (64.9%) 89 (67.4%)
#> >30 to <=60 msec 11 (8.2%) 9 (6.7%) 9 (6.8%)
#> >60 msec 52 (38.8%) 38 (28.4%) 34 (25.8%)
#> WEEK 3 DAY 22
#> Value at Visit
#> n 134 134 132
#> <=450 msec 106 (79.1%) 112 (83.6%) 118 (89.4%)
#> >450 to <=480 msec 13 (9.7%) 7 (5.2%) 3 (2.3%)
#> >480 to <=500 msec 4 (3.0%) 5 (3.7%) 2 (1.5%)
#> >500 msec 11 (8.2%) 10 (7.5%) 9 (6.8%)
#> Change from Baseline
#> n 134 134 132
#> <=30 msec 63 (47.0%) 80 (59.7%) 81 (61.4%)
#> >30 to <=60 msec 14 (10.4%) 8 (6.0%) 11 (8.3%)
#> >60 msec 57 (42.5%) 46 (34.3%) 40 (30.3%)
#> WEEK 4 DAY 29
#> Value at Visit
#> n 134 134 132
#> <=450 msec 117 (87.3%) 103 (76.9%) 114 (86.4%)
#> >450 to <=480 msec 7 (5.2%) 14 (10.4%) 6 (4.5%)
#> >480 to <=500 msec 4 (3.0%) 7 (5.2%) 3 (2.3%)
#> >500 msec 6 (4.5%) 10 (7.5%) 9 (6.8%)
#> Change from Baseline
#> n 134 134 132
#> <=30 msec 79 (59.0%) 80 (59.7%) 79 (59.8%)
#> >30 to <=60 msec 11 (8.2%) 7 (5.2%) 10 (7.6%)
#> >60 msec 44 (32.8%) 47 (35.1%) 43 (32.6%)
#> WEEK 5 DAY 36
#> Value at Visit
#> n 134 134 132
#> <=450 msec 107 (79.9%) 117 (87.3%) 112 (84.8%)
#> >450 to <=480 msec 16 (11.9%) 5 (3.7%) 13 (9.8%)
#> >480 to <=500 msec 5 (3.7%) 9 (6.7%) 3 (2.3%)
#> >500 msec 6 (4.5%) 3 (2.2%) 4 (3.0%)
#> Change from Baseline
#> n 134 134 132
#> <=30 msec 72 (53.7%) 82 (61.2%) 73 (55.3%)
#> >30 to <=60 msec 10 (7.5%) 11 (8.2%) 11 (8.3%)
#> >60 msec 52 (38.8%) 41 (30.6%) 48 (36.4%)2. ECG Actual Values and Changes from Baseline by Visit (removing default analyses)
The template have two default analyses of ADEG.AVALCAT1
and ADEG.CHGCAT1. To keep only the analyses needed, this
can be achieved by modifying the parameter summaryvars.
run(egt05_qtcat, syn_data, summaryvars = c("AVALCAT1"))
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Category (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————
#> QT Duration
#> BASELINE
#> n 134 134 132
#> <=450 msec 115 (85.8%) 117 (87.3%) 104 (78.8%)
#> >450 to <=480 msec 6 (4.5%) 10 (7.5%) 9 (6.8%)
#> >480 to <=500 msec 4 (3.0%) 3 (2.2%) 6 (4.5%)
#> >500 msec 9 (6.7%) 4 (3.0%) 13 (9.8%)
#> WEEK 1 DAY 8
#> n 134 134 132
#> <=450 msec 113 (84.3%) 106 (79.1%) 106 (80.3%)
#> >450 to <=480 msec 10 (7.5%) 10 (7.5%) 11 (8.3%)
#> >480 to <=500 msec 4 (3.0%) 4 (3.0%) 3 (2.3%)
#> >500 msec 7 (5.2%) 14 (10.4%) 12 (9.1%)
#> WEEK 2 DAY 15
#> n 134 134 132
#> <=450 msec 111 (82.8%) 114 (85.1%) 112 (84.8%)
#> >450 to <=480 msec 10 (7.5%) 9 (6.7%) 9 (6.8%)
#> >480 to <=500 msec 7 (5.2%) 2 (1.5%) 5 (3.8%)
#> >500 msec 6 (4.5%) 9 (6.7%) 6 (4.5%)
#> WEEK 3 DAY 22
#> n 134 134 132
#> <=450 msec 106 (79.1%) 112 (83.6%) 118 (89.4%)
#> >450 to <=480 msec 13 (9.7%) 7 (5.2%) 3 (2.3%)
#> >480 to <=500 msec 4 (3.0%) 5 (3.7%) 2 (1.5%)
#> >500 msec 11 (8.2%) 10 (7.5%) 9 (6.8%)
#> WEEK 4 DAY 29
#> n 134 134 132
#> <=450 msec 117 (87.3%) 103 (76.9%) 114 (86.4%)
#> >450 to <=480 msec 7 (5.2%) 14 (10.4%) 6 (4.5%)
#> >480 to <=500 msec 4 (3.0%) 7 (5.2%) 3 (2.3%)
#> >500 msec 6 (4.5%) 10 (7.5%) 9 (6.8%)
#> WEEK 5 DAY 36
#> n 134 134 132
#> <=450 msec 107 (79.9%) 117 (87.3%) 112 (84.8%)
#> >450 to <=480 msec 16 (11.9%) 5 (3.7%) 13 (9.8%)
#> >480 to <=500 msec 5 (3.7%) 9 (6.7%) 3 (2.3%)
#> >500 msec 6 (4.5%) 3 (2.2%) 4 (3.0%)
Study Drug Exposure (EXT01)
1. Study Drug Exposure
- The
ext01template displays total number of doses administered and total dose administered by default - The template does not include the column of total by default
run(ext01, syn_data)
#> PARCAT2 A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————
#> Drug A
#> Overall duration (days)
#> n 75 67 75
#> Mean (SD) 121.5 (70.7) 131.2 (78.5) 130.5 (73.1)
#> Median 116.0 127.0 126.0
#> Min - Max 15.0 - 249.0 1.0 - 250.0 1.0 - 246.0
#> Total dose administered
#> n 75 67 75
#> Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5)
#> Median 6720.0 6480.0 7200.0
#> Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0
#> Drug B
#> Overall duration (days)
#> n 59 67 57
#> Mean (SD) 111.0 (69.4) 113.7 (68.9) 137.5 (74.4)
#> Median 98.0 104.0 144.0
#> Min - Max 9.0 - 245.0 2.0 - 247.0 15.0 - 250.0
#> Total dose administered
#> n 59 67 57
#> Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7)
#> Median 6720.0 6240.0 6480.0
#> Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0
Laboratory Test Results and Change from Baseline by Visit
(LBT01)
1. Laboratory Test Results and Change from Baseline by Visit
- The
lbt01template produces the standard laboratory test results and change from baseline by visit.
- To select the SI/CV/LS results and the panel (chemistry/hematology/urinalysis/coagulation etc.) to display, user defines individual filters and apply to input datasets prior to running CHEVRON.
t_lb_chg <- run(lbt01, syn_data)
head(t_lb_chg, 20)
#> A: Drug X B: Placebo C: Combination
#> Change from Change from Change from
#> Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline
#> (N=134) (N=134) (N=134) (N=134) (N=132) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> BASELINE
#> n 134 134 132
#> Mean (SD) 19.786 (4.161) 20.153 (4.171) 20.451 (3.911)
#> Median 19.786 20.077 20.387
#> Min - Max 6.99 - 30.43 8.11 - 34.56 8.82 - 28.72
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 19.301 (3.981) -0.485 (5.850) 20.221 (3.974) 0.068 (6.036) 20.553 (3.895) 0.102 (5.461)
#> Median 19.209 -0.511 20.090 -0.725 20.402 0.025
#> Min - Max 8.86 - 27.32 -12.52 - 19.70 5.84 - 28.75 -12.29 - 17.41 9.87 - 30.70 -13.69 - 15.54
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 19.704 (4.233) -0.082 (6.003) 20.123 (4.265) -0.030 (6.263) 19.247 (3.592) -1.204 (5.485)
#> Median 19.168 0.038 19.986 -0.371 19.608 -0.482
#> Min - Max 7.17 - 30.53 -13.15 - 17.17 7.19 - 30.54 -18.37 - 14.39 8.11 - 26.68 -14.28 - 15.65
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 20.130 (3.757) 0.344 (5.761) 19.837 (3.871) -0.316 (5.604) 19.428 (3.944) -1.023 (5.550)
#> Median 20.044 0.451 19.873 -0.178 18.838 -1.065
Laboratory Abnormalities (LBT04)
1. Laboratory Abnormalities
- The
lbt04template produces the standard laboratory abnormalities summary.
- The template subsets to SI results by default.
- The laboratory tests and directions of abnormality in this template is data-driven. Table entries provide the number of patients with a during treatment laboratory value abnormality in the direction specified among patients without this abnormality at baseline.
run(lbt04, syn_data)
#> Laboratory Test A: Drug X B: Placebo C: Combination
#> Direction of Abnormality (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————
#> CHEMISTRY
#> Alanine Aminotransferase Measurement
#> Low 7/45 (15.6%) 6/51 (11.8%) 4/61 (6.6%)
#> High 4/45 (8.9%) 6/45 (13.3%) 4/62 (6.5%)
#> C-Reactive Protein Measurement
#> Low 6/55 (10.9%) 5/61 (8.2%) 6/51 (11.8%)
#> High 6/53 (11.3%) 7/55 (12.7%) 2/48 (4.2%)
#> Immunoglobulin A Measurement
#> Low 4/43 (9.3%) 9/51 (17.6%) 8/52 (15.4%)
#> High 7/42 (16.7%) 7/49 (14.3%) 5/52 (9.6%)
#> COAGULATION
#> Alanine Aminotransferase Measurement
#> Low 4/54 (7.4%) 5/53 (9.4%) 4/48 (8.3%)
#> High 9/53 (17.0%) 7/50 (14.0%) 6/48 (12.5%)
#> C-Reactive Protein Measurement
#> Low 7/56 (12.5%) 5/48 (10.4%) 5/50 (10.0%)
#> High 8/52 (15.4%) 3/46 (6.5%) 5/46 (10.9%)
#> Immunoglobulin A Measurement
#> Low 8/50 (16.0%) 8/57 (14.0%) 2/54 (3.7%)
#> High 6/48 (12.5%) 8/65 (12.3%) 2/52 (3.8%)
#> HEMATOLOGY
#> Alanine Aminotransferase Measurement
#> Low 3/48 (6.2%) 4/46 (8.7%) 6/59 (10.2%)
#> High 5/47 (10.6%) 7/45 (15.6%) 8/55 (14.5%)
#> C-Reactive Protein Measurement
#> Low 6/49 (12.2%) 6/45 (13.3%) 11/57 (19.3%)
#> High 3/44 (6.8%) 3/46 (6.5%) 6/53 (11.3%)
#> Immunoglobulin A Measurement
#> Low 5/56 (8.9%) 8/53 (15.1%) 9/50 (18.0%)
#> High 7/57 (12.3%) 4/56 (7.1%) 10/52 (19.2%)
Laboratory Abnormalities with Single and Replicated Marked
(LBT05)
1. Laboratory Abnormalities with Single and Replicated Marked
- The
lbt05template produces the standard laboratory abnormalities summary for marked abnormalities.
- The laboratory tests and directions of abnormality in this template is currently data-driven. The standard metadata for Safety Lab Standardization will be incorporated in future release.
run(lbt05, syn_data)
#> Laboratory Test A: Drug X B: Placebo C: Combination
#> Direction of Abnormality (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement (n) 119 122 111
#> Low
#> Single, not last 1 (0.8%) 2 (1.6%) 2 (1.8%)
#> Last or replicated 2 (1.7%) 7 (5.7%) 0
#> Any Abnormality 3 (2.5%) 9 (7.4%) 2 (1.8%)
#> High
#> Single, not last 4 (3.4%) 4 (3.3%) 1 (0.9%)
#> Last or replicated 2 (1.7%) 5 (4.1%) 4 (3.6%)
#> Any Abnormality 6 (5.0%) 9 (7.4%) 5 (4.5%)
#> C-Reactive Protein Measurement (n) 124 114 114
#> Low
#> Single, not last 1 (0.8%) 0 3 (2.6%)
#> Last or replicated 5 (4.0%) 6 (5.3%) 2 (1.8%)
#> Any Abnormality 6 (4.8%) 6 (5.3%) 5 (4.4%)
#> High
#> Single, not last 2 (1.6%) 1 (0.9%) 2 (1.8%)
#> Last or replicated 5 (4.0%) 5 (4.4%) 5 (4.4%)
#> Any Abnormality 7 (5.6%) 6 (5.3%) 7 (6.1%)
#> Immunoglobulin A Measurement (n) 112 116 113
#> Low
#> Single, not last 1 (0.9%) 3 (2.6%) 4 (3.5%)
#> Last or replicated 4 (3.6%) 3 (2.6%) 2 (1.8%)
#> Any Abnormality 5 (4.5%) 6 (5.2%) 6 (5.3%)
#> High
#> Single, not last 1 (0.9%) 1 (0.9%) 2 (1.8%)
#> Last or replicated 1 (0.9%) 5 (4.3%) 3 (2.7%)
#> Any Abnormality 2 (1.8%) 6 (5.2%) 5 (4.4%)
Laboratory Abnormalities by Visit and Baseline Status
(LBT06)
1. Laboratory Abnormalities by Visit and Baseline Status
- The
lbt06template produces the standard laboratory abnormalities by visit and baseline status summary.
run(lbt06, syn_data)
#> Visit
#> Abnormality at Visit A: Drug X B: Placebo C: Combination
#> Baseline Status (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> WEEK 1 DAY 8
#> Low
#> Not low 3/39 (7.7%) 2/40 (5%) 1/37 (2.7%)
#> Low 1/4 (25%) 0/2 0/7
#> Total 4/43 (9.3%) 2/42 (4.8%) 1/44 (2.3%)
#> High
#> Not high 3/42 (7.1%) 3/35 (8.6%) 4/41 (9.8%)
#> High 0/1 0/7 0/3
#> Total 3/43 (7%) 3/42 (7.1%) 4/44 (9.1%)
#> WEEK 2 DAY 15
#> Low
#> Not low 5/29 (17.2%) 2/30 (6.7%) 7/45 (15.6%)
#> Low 1/2 (50%) 0/5 0/7
#> Total 6/31 (19.4%) 2/35 (5.7%) 7/52 (13.5%)
#> High
#> Not high 1/26 (3.8%) 4/33 (12.1%) 4/45 (8.9%)
#> High 0/5 0/2 1/7 (14.3%)
#> Total 1/31 (3.2%) 4/35 (11.4%) 5/52 (9.6%)
#> WEEK 3 DAY 22
#> Low
#> Not low 2/34 (5.9%) 3/34 (8.8%) 1/35 (2.9%)
#> Low 1/3 (33.3%) 0/0 1/4 (25%)
#> Total 3/37 (8.1%) 3/34 (8.8%) 2/39 (5.1%)
#> High
#> Not high 5/33 (15.2%) 5/29 (17.2%) 3/34 (8.8%)
#> High 1/4 (25%) 0/5 0/5
#> Total 6/37 (16.2%) 5/34 (14.7%) 3/39 (7.7%)
#> WEEK 4 DAY 29
#> Low
#> Not low 2/40 (5%) 2/39 (5.1%) 1/38 (2.6%)
#> Low 0/2 1/4 (25%) 0/5
#> Total 2/42 (4.8%) 3/43 (7%) 1/43 (2.3%)
#> High
#> Not high 5/36 (13.9%) 1/34 (2.9%) 6/39 (15.4%)
#> High 1/6 (16.7%) 1/9 (11.1%) 0/4
#> Total 6/42 (14.3%) 2/43 (4.7%) 6/43 (14%)
#> WEEK 5 DAY 36
#> Low
#> Not low 2/35 (5.7%) 6/35 (17.1%) 4/44 (9.1%)
#> Low 1/3 (33.3%) 2/8 (25%) 0/3
#> Total 3/38 (7.9%) 8/43 (18.6%) 4/47 (8.5%)
#> High
#> Not high 4/38 (10.5%) 7/38 (18.4%) 1/41 (2.4%)
#> High 0/0 0/5 0/6
#> Total 4/38 (10.5%) 7/43 (16.3%) 1/47 (2.1%)
#> C-Reactive Protein Measurement
#> WEEK 1 DAY 8
#> Low
#> Not low 4/46 (8.7%) 2/40 (5%) 4/42 (9.5%)
#> Low 0/5 0/2 0/2
#> Total 4/51 (7.8%) 2/42 (4.8%) 4/44 (9.1%)
#> High
#> Not high 6/44 (13.6%) 4/37 (10.8%) 1/35 (2.9%)
#> High 0/7 1/5 (20%) 0/9
#> Total 6/51 (11.8%) 5/42 (11.9%) 1/44 (2.3%)
#> WEEK 2 DAY 15
#> Low
#> Not low 4/39 (10.3%) 3/29 (10.3%) 2/33 (6.1%)
#> Low 1/3 (33.3%) 0/2 0/3
#> Total 5/42 (11.9%) 3/31 (9.7%) 2/36 (5.6%)
#> High
#> Not high 2/36 (5.6%) 3/27 (11.1%) 3/27 (11.1%)
#> High 0/6 1/4 (25%) 0/9
#> Total 2/42 (4.8%) 4/31 (12.9%) 3/36 (8.3%)
#> WEEK 3 DAY 22
#> Low
#> Not low 3/37 (8.1%) 6/46 (13%) 8/44 (18.2%)
#> Low 0/3 0/5 0/6
#> Total 3/40 (7.5%) 6/51 (11.8%) 8/50 (16%)
#> High
#> Not high 2/34 (5.9%) 2/44 (4.5%) 1/43 (2.3%)
#> High 0/6 0/7 0/7
#> Total 2/40 (5%) 2/51 (3.9%) 1/50 (2%)
#> WEEK 4 DAY 29
#> Low
#> Not low 3/42 (7.1%) 1/36 (2.8%) 4/34 (11.8%)
#> Low 0/4 1/2 (50%) 0/5
#> Total 3/46 (6.5%) 2/38 (5.3%) 4/39 (10.3%)
#> High
#> Not high 3/40 (7.5%) 1/35 (2.9%) 5/34 (14.7%)
#> High 1/6 (16.7%) 1/3 (33.3%) 0/5
#> Total 4/46 (8.7%) 2/38 (5.3%) 5/39 (12.8%)
#> WEEK 5 DAY 36
#> Low
#> Not low 5/34 (14.7%) 4/38 (10.5%) 5/41 (12.2%)
#> Low 1/6 (16.7%) 0/4 1/5 (20%)
#> Total 6/40 (15%) 4/42 (9.5%) 6/46 (13%)
#> High
#> Not high 4/35 (11.4%) 4/35 (11.4%) 3/39 (7.7%)
#> High 0/5 0/7 1/7 (14.3%)
#> Total 4/40 (10%) 4/42 (9.5%) 4/46 (8.7%)
#> Immunoglobulin A Measurement
#> WEEK 1 DAY 8
#> Low
#> Not low 2/38 (5.3%) 3/38 (7.9%) 3/30 (10%)
#> Low 1/7 (14.3%) 1/4 (25%) 1/4 (25%)
#> Total 3/45 (6.7%) 4/42 (9.5%) 4/34 (11.8%)
#> High
#> Not high 2/38 (5.3%) 3/37 (8.1%) 1/30 (3.3%)
#> High 2/7 (28.6%) 1/5 (20%) 1/4 (25%)
#> Total 4/45 (8.9%) 4/42 (9.5%) 2/34 (5.9%)
#> WEEK 2 DAY 15
#> Low
#> Not low 2/36 (5.6%) 5/45 (11.1%) 5/43 (11.6%)
#> Low 1/4 (25%) 0/4 1/6 (16.7%)
#> Total 3/40 (7.5%) 5/49 (10.2%) 6/49 (12.2%)
#> High
#> Not high 7/39 (17.9%) 4/44 (9.1%) 5/46 (10.9%)
#> High 0/1 0/5 0/3
#> Total 7/40 (17.5%) 4/49 (8.2%) 5/49 (10.2%)
#> WEEK 3 DAY 22
#> Low
#> Not low 7/43 (16.3%) 4/40 (10%) 2/38 (5.3%)
#> Low 0/5 0/10 2/4 (50%)
#> Total 7/48 (14.6%) 4/50 (8%) 4/42 (9.5%)
#> High
#> Not high 2/41 (4.9%) 5/48 (10.4%) 5/36 (13.9%)
#> High 0/7 0/2 0/6
#> Total 2/48 (4.2%) 5/50 (10%) 5/42 (11.9%)
#> WEEK 4 DAY 29
#> Low
#> Not low 2/29 (6.9%) 7/43 (16.3%) 4/46 (8.7%)
#> Low 0/5 0/10 0/2
#> Total 2/34 (5.9%) 7/53 (13.2%) 4/48 (8.3%)
#> High
#> Not high 6/29 (20.7%) 4/49 (8.2%) 3/44 (6.8%)
#> High 0/5 1/4 (25%) 1/4 (25%)
#> Total 6/34 (17.6%) 5/53 (9.4%) 4/48 (8.3%)
#> WEEK 5 DAY 36
#> Low
#> Not low 4/41 (9.8%) 6/39 (15.4%) 5/38 (13.2%)
#> Low 0/2 0/5 0/2
#> Total 4/43 (9.3%) 6/44 (13.6%) 5/40 (12.5%)
#> High
#> Not high 3/37 (8.1%) 5/39 (12.8%) 4/38 (10.5%)
#> High 0/6 0/5 1/2 (50%)
#> Total 3/43 (7%) 5/44 (11.4%) 5/40 (12.5%)
Laboratory Test Results with Highest NCI CTCAE
Grade Post-Baseline (LBT07)
1. Laboratory Test Results with Highest
NCI CTCAE Grade Post-Baseline
- The
lbt07template produces the standard laboratory test results with highestNCI CTCAEgrade post-baseline summary.
- The laboratory tests and grades in this template is currently
data-driven. The standard metadata for possible lab tests and
corresponding
NCI CTCAEgrade will be incorporated in future release.
run(lbt07, syn_data)
#> Parameter
#> Direction of Abnormality A: Drug X B: Placebo C: Combination
#> Highest NCI CTCAE Grade (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement (n) 134 134 132
#> LOW
#> 1 14 (10.4%) 15 (11.2%) 10 (7.6%)
#> 2 13 (9.7%) 18 (13.4%) 11 (8.3%)
#> 3 20 (14.9%) 12 (9.0%) 10 (7.6%)
#> 4 7 (5.2%) 8 (6.0%) 10 (7.6%)
#> Any 54 (40.3%) 53 (39.6%) 41 (31.1%)
#> HIGH
#> 1 18 (13.4%) 16 (11.9%) 18 (13.6%)
#> 2 15 (11.2%) 13 (9.7%) 18 (13.6%)
#> 3 10 (7.5%) 16 (11.9%) 13 (9.8%)
#> 4 12 (9.0%) 11 (8.2%) 13 (9.8%)
#> Any 55 (41.0%) 56 (41.8%) 62 (47.0%)
#> C-Reactive Protein Measurement (n) 134 134 132
#> LOW
#> 1 16 (11.9%) 19 (14.2%) 15 (11.4%)
#> 2 21 (15.7%) 13 (9.7%) 16 (12.1%)
#> 3 12 (9.0%) 9 (6.7%) 18 (13.6%)
#> 4 11 (8.2%) 7 (5.2%) 5 (3.8%)
#> Any 60 (44.8%) 48 (35.8%) 54 (40.9%)
#> HIGH
#> 1 17 (12.7%) 15 (11.2%) 9 (6.8%)
#> 2 15 (11.2%) 16 (11.9%) 13 (9.8%)
#> 3 16 (11.9%) 12 (9.0%) 14 (10.6%)
#> 4 12 (9.0%) 12 (9.0%) 10 (7.6%)
#> Any 60 (44.8%) 55 (41.0%) 46 (34.8%)
#> Immunoglobulin A Measurement (n) 134 134 132
#> LOW
#> 1 17 (12.7%) 23 (17.2%) 17 (12.9%)
#> 2 12 (9.0%) 15 (11.2%) 14 (10.6%)
#> 3 15 (11.2%) 11 (8.2%) 14 (10.6%)
#> 4 10 (7.5%) 16 (11.9%) 10 (7.6%)
#> Any 54 (40.3%) 65 (48.5%) 55 (41.7%)
#> HIGH
#> 1 25 (18.7%) 14 (10.4%) 13 (9.8%)
#> 2 14 (10.4%) 20 (14.9%) 16 (12.1%)
#> 3 12 (9.0%) 13 (9.7%) 17 (12.9%)
#> 4 11 (8.2%) 13 (9.7%) 4 (3.0%)
#> Any 62 (46.3%) 60 (44.8%) 50 (37.9%)
Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (LBT14)
1. Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (High)
To produce the standard laboratory test results shift table - highest
NCI-CTCAE grade post-baseline by baseline
NCI-CTCAE grade summary for high abnormalities, use the
lbt14 template and set the parameter
direction to high.
run(lbt14, syn_data, direction = "high")
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> Not High 121 118 118
#> Not High 72 (53.7%) 70 (52.2%) 59 (44.7%)
#> 1 16 (11.9%) 13 (9.7%) 17 (12.9%)
#> 2 13 (9.7%) 12 (9.0%) 18 (13.6%)
#> 3 9 (6.7%) 14 (10.4%) 12 (9.1%)
#> 4 11 (8.2%) 9 (6.7%) 12 (9.1%)
#> 1 4 4 3
#> Not High 1 (0.7%) 1 (0.7%) 2 (1.5%)
#> 1 1 (0.7%) 0 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 1 (0.7%) 2 (1.5%) 0
#> 2 4 4 4
#> Not High 3 (2.2%) 3 (2.2%) 3 (2.3%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 0 0
#> 3 2 5 5
#> Not High 2 (1.5%) 2 (1.5%) 4 (3.0%)
#> 1 0 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 4 0 0 1 (0.8%)
#> 4 3 3 2
#> Not High 1 (0.7%) 2 (1.5%) 2 (1.5%)
#> 1 1 (0.7%) 0 0
#> 3 1 (0.7%) 1 (0.7%) 0
#> C-Reactive Protein Measurement
#> Not High 115 115 114
#> Not High 60 (44.8%) 68 (50.7%) 70 (53.0%)
#> 1 17 (12.7%) 13 (9.7%) 9 (6.8%)
#> 2 12 (9.0%) 14 (10.4%) 13 (9.8%)
#> 3 16 (11.9%) 10 (7.5%) 13 (9.8%)
#> 4 10 (7.5%) 10 (7.5%) 9 (6.8%)
#> 1 5 5 5
#> Not High 4 (3.0%) 3 (2.2%) 5 (3.8%)
#> 2 0 2 (1.5%) 0
#> 4 1 (0.7%) 0 0
#> 2 6 5 5
#> Not High 3 (2.2%) 3 (2.2%) 4 (3.0%)
#> 1 0 1 (0.7%) 0
#> 2 2 (1.5%) 0 0
#> 4 1 (0.7%) 1 (0.7%) 1 (0.8%)
#> 3 2 3 5
#> Not High 2 (1.5%) 1 (0.7%) 4 (3.0%)
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 0 1 (0.7%) 0
#> 4 6 6 3
#> Not High 5 (3.7%) 4 (3.0%) 3 (2.3%)
#> 1 0 1 (0.7%) 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 0
#> Immunoglobulin A Measurement
#> Not High 119 123 119
#> Not High 61 (45.5%) 69 (51.5%) 74 (56.1%)
#> 1 24 (17.9%) 12 (9.0%) 13 (9.8%)
#> 2 13 (9.7%) 20 (14.9%) 12 (9.1%)
#> 3 11 (8.2%) 11 (8.2%) 16 (12.1%)
#> 4 10 (7.5%) 11 (8.2%) 4 (3.0%)
#> 1 2 4 6
#> Not High 2 (1.5%) 2 (1.5%) 5 (3.8%)
#> 2 0 0 1 (0.8%)
#> 4 0 2 (1.5%) 0
#> 2 4 4 3
#> Not High 3 (2.2%) 2 (1.5%) 1 (0.8%)
#> 1 0 2 (1.5%) 0
#> 2 0 0 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 0
#> 3 5 2 2
#> Not High 3 (2.2%) 0 1 (0.8%)
#> 1 1 (0.7%) 0 0
#> 2 0 0 1 (0.8%)
#> 3 1 (0.7%) 2 (1.5%) 0
#> 4 4 1 2
#> Not High 3 (2.2%) 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 0 1 (0.8%)
2. Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (Low)
To produce the standard laboratory test results shift table - highest
NCI-CTCAE grade post-baseline by baseline
NCI-CTCAE grade summary for high abnormalities, use the
lbt14 template and the parameter
direction is low by default.
run(lbt14, syn_data)
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> Not Low 124 122 117
#> Not Low 74 (55.2%) 76 (56.7%) 80 (60.6%)
#> 1 13 (9.7%) 12 (9.0%) 9 (6.8%)
#> 2 13 (9.7%) 16 (11.9%) 11 (8.3%)
#> 3 17 (12.7%) 11 (8.2%) 9 (6.8%)
#> 4 7 (5.2%) 7 (5.2%) 8 (6.1%)
#> 1 3 6 7
#> Not Low 0 2 (1.5%) 5 (3.8%)
#> 1 1 (0.7%) 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 3 2 (1.5%) 1 (0.7%) 0
#> 4 0 0 2 (1.5%)
#> 2 2 1 4
#> Not Low 2 (1.5%) 0 3 (2.3%)
#> 2 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 3 2 3 4
#> Not Low 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 4 3 2 0
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 3 1 (0.7%) 0 0
#> 4 0 1 (0.7%) 0
#> C-Reactive Protein Measurement
#> Not Low 122 125 120
#> Not Low 67 (50.0%) 81 (60.4%) 70 (53.0%)
#> 1 14 (10.4%) 17 (12.7%) 13 (9.8%)
#> 2 20 (14.9%) 11 (8.2%) 16 (12.1%)
#> 3 12 (9.0%) 9 (6.7%) 17 (12.9%)
#> 4 9 (6.7%) 7 (5.2%) 4 (3.0%)
#> 1 2 5 5
#> Not Low 0 3 (2.2%) 4 (3.0%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 1 (0.7%) 0
#> 4 1 (0.7%) 0 0
#> 2 5 1 1
#> Not Low 3 (2.2%) 0 1 (0.8%)
#> 1 2 (1.5%) 0 0
#> 2 0 1 (0.7%) 0
#> 3 2 2 1
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 1 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 4 3 1 5
#> Not Low 2 (1.5%) 1 (0.7%) 3 (2.3%)
#> 1 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 1 (0.8%)
#> Immunoglobulin A Measurement
#> Not Low 120 119 120
#> Not Low 69 (51.5%) 58 (43.3%) 70 (53.0%)
#> 1 16 (11.9%) 20 (14.9%) 16 (12.1%)
#> 2 12 (9.0%) 14 (10.4%) 14 (10.6%)
#> 3 14 (10.4%) 11 (8.2%) 13 (9.8%)
#> 4 9 (6.7%) 16 (11.9%) 7 (5.3%)
#> 1 8 8 3
#> Not Low 7 (5.2%) 4 (3.0%) 2 (1.5%)
#> 1 1 (0.7%) 3 (2.2%) 0
#> 2 0 1 (0.7%) 0
#> 4 0 0 1 (0.8%)
#> 2 2 1 2
#> Not Low 2 (1.5%) 1 (0.7%) 2 (1.5%)
#> 3 3 3 4
#> Not Low 1 (0.7%) 3 (2.2%) 2 (1.5%)
#> 1 0 0 1 (0.8%)
#> 3 1 (0.7%) 0 0
#> 4 1 (0.7%) 0 1 (0.8%)
#> 4 1 3 3
#> Not Low 1 (0.7%) 3 (2.2%) 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 0 0 1 (0.8%)
3. Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (High) Without Patients with Missing
Baseline
To exclude patients with missing baseline grade, set the parameter
gr_missing to excl.
run(lbt14, syn_data, direction = "high", gr_missing = "excl")
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> Not High 121 118 118
#> Not High 72 (53.7%) 70 (52.2%) 59 (44.7%)
#> 1 16 (11.9%) 13 (9.7%) 17 (12.9%)
#> 2 13 (9.7%) 12 (9.0%) 18 (13.6%)
#> 3 9 (6.7%) 14 (10.4%) 12 (9.1%)
#> 4 11 (8.2%) 9 (6.7%) 12 (9.1%)
#> 1 4 4 3
#> Not High 1 (0.7%) 1 (0.7%) 2 (1.5%)
#> 1 1 (0.7%) 0 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 1 (0.7%) 2 (1.5%) 0
#> 2 4 4 4
#> Not High 3 (2.2%) 3 (2.2%) 3 (2.3%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 0 0
#> 3 2 5 5
#> Not High 2 (1.5%) 2 (1.5%) 4 (3.0%)
#> 1 0 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 4 0 0 1 (0.8%)
#> 4 3 3 2
#> Not High 1 (0.7%) 2 (1.5%) 2 (1.5%)
#> 1 1 (0.7%) 0 0
#> 3 1 (0.7%) 1 (0.7%) 0
#> C-Reactive Protein Measurement
#> Not High 115 115 114
#> Not High 60 (44.8%) 68 (50.7%) 70 (53.0%)
#> 1 17 (12.7%) 13 (9.7%) 9 (6.8%)
#> 2 12 (9.0%) 14 (10.4%) 13 (9.8%)
#> 3 16 (11.9%) 10 (7.5%) 13 (9.8%)
#> 4 10 (7.5%) 10 (7.5%) 9 (6.8%)
#> 1 5 5 5
#> Not High 4 (3.0%) 3 (2.2%) 5 (3.8%)
#> 2 0 2 (1.5%) 0
#> 4 1 (0.7%) 0 0
#> 2 6 5 5
#> Not High 3 (2.2%) 3 (2.2%) 4 (3.0%)
#> 1 0 1 (0.7%) 0
#> 2 2 (1.5%) 0 0
#> 4 1 (0.7%) 1 (0.7%) 1 (0.8%)
#> 3 2 3 5
#> Not High 2 (1.5%) 1 (0.7%) 4 (3.0%)
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 0 1 (0.7%) 0
#> 4 6 6 3
#> Not High 5 (3.7%) 4 (3.0%) 3 (2.3%)
#> 1 0 1 (0.7%) 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 0
#> Immunoglobulin A Measurement
#> Not High 119 123 119
#> Not High 61 (45.5%) 69 (51.5%) 74 (56.1%)
#> 1 24 (17.9%) 12 (9.0%) 13 (9.8%)
#> 2 13 (9.7%) 20 (14.9%) 12 (9.1%)
#> 3 11 (8.2%) 11 (8.2%) 16 (12.1%)
#> 4 10 (7.5%) 11 (8.2%) 4 (3.0%)
#> 1 2 4 6
#> Not High 2 (1.5%) 2 (1.5%) 5 (3.8%)
#> 2 0 0 1 (0.8%)
#> 4 0 2 (1.5%) 0
#> 2 4 4 3
#> Not High 3 (2.2%) 2 (1.5%) 1 (0.8%)
#> 1 0 2 (1.5%) 0
#> 2 0 0 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 0
#> 3 5 2 2
#> Not High 3 (2.2%) 0 1 (0.8%)
#> 1 1 (0.7%) 0 0
#> 2 0 0 1 (0.8%)
#> 3 1 (0.7%) 2 (1.5%) 0
#> 4 4 1 2
#> Not High 3 (2.2%) 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 0 1 (0.8%)
4. Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (Low) with Missing Baseline Considered as
Grade 0
To count patients with missing baseline grade as grade 0, set the
parameter gr_missing to gr_0.
run(lbt14, syn_data, gr_missing = "gr_0")
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> 1 3 6 7
#> Not Low 0 2 (1.5%) 5 (3.8%)
#> 1 1 (0.7%) 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 3 2 (1.5%) 1 (0.7%) 0
#> 4 0 0 2 (1.5%)
#> 2 2 1 4
#> Not Low 2 (1.5%) 0 3 (2.3%)
#> 2 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 3 2 3 4
#> Not Low 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 4 3 2 0
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 3 1 (0.7%) 0 0
#> 4 0 1 (0.7%) 0
#> Not Low 124 122 117
#> Not Low 74 (55.2%) 76 (56.7%) 80 (60.6%)
#> 1 13 (9.7%) 12 (9.0%) 9 (6.8%)
#> 2 13 (9.7%) 16 (11.9%) 11 (8.3%)
#> 3 17 (12.7%) 11 (8.2%) 9 (6.8%)
#> 4 7 (5.2%) 7 (5.2%) 8 (6.1%)
#> C-Reactive Protein Measurement
#> 1 2 5 5
#> Not Low 0 3 (2.2%) 4 (3.0%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 1 (0.7%) 0
#> 4 1 (0.7%) 0 0
#> 2 5 1 1
#> Not Low 3 (2.2%) 0 1 (0.8%)
#> 1 2 (1.5%) 0 0
#> 2 0 1 (0.7%) 0
#> 3 2 2 1
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 1 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 4 3 1 5
#> Not Low 2 (1.5%) 1 (0.7%) 3 (2.3%)
#> 1 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 1 (0.8%)
#> Not Low 122 125 120
#> Not Low 67 (50.0%) 81 (60.4%) 70 (53.0%)
#> 1 14 (10.4%) 17 (12.7%) 13 (9.8%)
#> 2 20 (14.9%) 11 (8.2%) 16 (12.1%)
#> 3 12 (9.0%) 9 (6.7%) 17 (12.9%)
#> 4 9 (6.7%) 7 (5.2%) 4 (3.0%)
#> Immunoglobulin A Measurement
#> 1 8 8 3
#> Not Low 7 (5.2%) 4 (3.0%) 2 (1.5%)
#> 1 1 (0.7%) 3 (2.2%) 0
#> 2 0 1 (0.7%) 0
#> 4 0 0 1 (0.8%)
#> 2 2 1 2
#> Not Low 2 (1.5%) 1 (0.7%) 2 (1.5%)
#> 3 3 3 4
#> Not Low 1 (0.7%) 3 (2.2%) 2 (1.5%)
#> 1 0 0 1 (0.8%)
#> 3 1 (0.7%) 0 0
#> 4 1 (0.7%) 0 1 (0.8%)
#> 4 1 3 3
#> Not Low 1 (0.7%) 3 (2.2%) 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 0 0 1 (0.8%)
#> Not Low 120 119 120
#> Not Low 69 (51.5%) 58 (43.3%) 70 (53.0%)
#> 1 16 (11.9%) 20 (14.9%) 16 (12.1%)
#> 2 12 (9.0%) 14 (10.4%) 14 (10.6%)
#> 3 14 (10.4%) 11 (8.2%) 13 (9.8%)
#> 4 9 (6.7%) 16 (11.9%) 7 (5.3%)
4. Laboratory Test Results Shift Table - Highest
NCI-CTCAE Grade Post-Baseline by Baseline
NCI-CTCAE Grade (with fill in of grades)
To display all possible grades even if they do not occur in the data,
set the parameter prune_0 to FALSE.
run(lbt14, syn_data, direction = "high", prune_0 = FALSE)
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> Not High 121 118 118
#> Not High 72 (53.7%) 70 (52.2%) 59 (44.7%)
#> Missing 0 0 0
#> 1 16 (11.9%) 13 (9.7%) 17 (12.9%)
#> 2 13 (9.7%) 12 (9.0%) 18 (13.6%)
#> 3 9 (6.7%) 14 (10.4%) 12 (9.1%)
#> 4 11 (8.2%) 9 (6.7%) 12 (9.1%)
#> 1 4 4 3
#> Not High 1 (0.7%) 1 (0.7%) 2 (1.5%)
#> Missing 0 0 0
#> 1 1 (0.7%) 0 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 1 (0.7%) 2 (1.5%) 0
#> 2 4 4 4
#> Not High 3 (2.2%) 3 (2.2%) 3 (2.3%)
#> Missing 0 0 0
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 0 0
#> 3 0 0 0
#> 4 0 0 0
#> 3 2 5 5
#> Not High 2 (1.5%) 2 (1.5%) 4 (3.0%)
#> Missing 0 0 0
#> 1 0 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 3 0 0 0
#> 4 0 0 1 (0.8%)
#> 4 3 3 2
#> Not High 1 (0.7%) 2 (1.5%) 2 (1.5%)
#> Missing 0 0 0
#> 1 1 (0.7%) 0 0
#> 2 0 0 0
#> 3 1 (0.7%) 1 (0.7%) 0
#> 4 0 0 0
#> Missing 0 0 0
#> Not High 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Missing 0 0 0
#> C-Reactive Protein Measurement
#> Not High 115 115 114
#> Not High 60 (44.8%) 68 (50.7%) 70 (53.0%)
#> Missing 0 0 0
#> 1 17 (12.7%) 13 (9.7%) 9 (6.8%)
#> 2 12 (9.0%) 14 (10.4%) 13 (9.8%)
#> 3 16 (11.9%) 10 (7.5%) 13 (9.8%)
#> 4 10 (7.5%) 10 (7.5%) 9 (6.8%)
#> 1 5 5 5
#> Not High 4 (3.0%) 3 (2.2%) 5 (3.8%)
#> Missing 0 0 0
#> 1 0 0 0
#> 2 0 2 (1.5%) 0
#> 3 0 0 0
#> 4 1 (0.7%) 0 0
#> 2 6 5 5
#> Not High 3 (2.2%) 3 (2.2%) 4 (3.0%)
#> Missing 0 0 0
#> 1 0 1 (0.7%) 0
#> 2 2 (1.5%) 0 0
#> 3 0 0 0
#> 4 1 (0.7%) 1 (0.7%) 1 (0.8%)
#> 3 2 3 5
#> Not High 2 (1.5%) 1 (0.7%) 4 (3.0%)
#> Missing 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> 3 0 1 (0.7%) 1 (0.8%)
#> 4 0 1 (0.7%) 0
#> 4 6 6 3
#> Not High 5 (3.7%) 4 (3.0%) 3 (2.3%)
#> Missing 0 0 0
#> 1 0 1 (0.7%) 0
#> 2 1 (0.7%) 0 0
#> 3 0 1 (0.7%) 0
#> 4 0 0 0
#> Missing 0 0 0
#> Not High 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Missing 0 0 0
#> Immunoglobulin A Measurement
#> Not High 119 123 119
#> Not High 61 (45.5%) 69 (51.5%) 74 (56.1%)
#> Missing 0 0 0
#> 1 24 (17.9%) 12 (9.0%) 13 (9.8%)
#> 2 13 (9.7%) 20 (14.9%) 12 (9.1%)
#> 3 11 (8.2%) 11 (8.2%) 16 (12.1%)
#> 4 10 (7.5%) 11 (8.2%) 4 (3.0%)
#> 1 2 4 6
#> Not High 2 (1.5%) 2 (1.5%) 5 (3.8%)
#> Missing 0 0 0
#> 1 0 0 0
#> 2 0 0 1 (0.8%)
#> 3 0 0 0
#> 4 0 2 (1.5%) 0
#> 2 4 4 3
#> Not High 3 (2.2%) 2 (1.5%) 1 (0.8%)
#> Missing 0 0 0
#> 1 0 2 (1.5%) 0
#> 2 0 0 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 0
#> 3 5 2 2
#> Not High 3 (2.2%) 0 1 (0.8%)
#> Missing 0 0 0
#> 1 1 (0.7%) 0 0
#> 2 0 0 1 (0.8%)
#> 3 1 (0.7%) 2 (1.5%) 0
#> 4 0 0 0
#> 4 4 1 2
#> Not High 3 (2.2%) 1 (0.7%) 1 (0.8%)
#> Missing 0 0 0
#> 1 0 0 0
#> 2 1 (0.7%) 0 1 (0.8%)
#> 3 0 0 0
#> 4 0 0 0
#> Missing 0 0 0
#> Not High 0 0 0
#> 1 0 0 0
#> 2 0 0 0
#> 3 0 0 0
#> 4 0 0 0
#> Missing 0 0 0
Medical History (MHT01)
1. Medical History
- The
mht01template displays medical conditions by MedDRA system organ class and Preferred Name by default.
- The default treatment variable is
ADSL.ARM.
- The user is expected to use filter to subset medical conditions
prior to or on entering study.
- By default, the template produces the overall ‘total number of
conditions’ as well as the ‘total number of conditions’ per body system
after the summary of patients.
5）This template currently does not support sorting MedDRA system organ class and preferred names by order of frequency.
run(mht01, syn_data)
#> MedDRA System Organ Class A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one condition 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Total number of conditions 609 622 703
#> cl A
#> Total number of patients with at least one condition 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of conditions 132 130 160
#> trm A_1/2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> trm A_2/2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B
#> Total number of patients with at least one condition 96 (71.6%) 89 (66.4%) 97 (73.5%)
#> Total number of conditions 185 198 205
#> trm B_3/3 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> trm B_2/3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> trm B_1/3 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C
#> Total number of patients with at least one condition 67 (50.0%) 75 (56.0%) 79 (59.8%)
#> Total number of conditions 103 116 129
#> trm C_2/2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> trm C_1/2 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> cl D
#> Total number of patients with at least one condition 96 (71.6%) 90 (67.2%) 98 (74.2%)
#> Total number of conditions 189 178 209
#> trm D_3/3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> trm D_1/3 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> trm D_2/3 48 (35.8%) 42 (31.3%) 50 (37.9%)2. Medical History showing additional column ‘All Patients’
run(mht01, syn_data, lbl_overall = "All Patients")
#> MedDRA System Organ Class A: Drug X B: Placebo C: Combination All Patients
#> MedDRA Preferred Term (N=134) (N=134) (N=132) (N=400)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one condition 122 (91.0%) 123 (91.8%) 120 (90.9%) 365 (91.2%)
#> Total number of conditions 609 622 703 1934
#> cl A
#> Total number of patients with at least one condition 78 (58.2%) 75 (56.0%) 89 (67.4%) 242 (60.5%)
#> Total number of conditions 132 130 160 422
#> trm A_1/2 50 (37.3%) 45 (33.6%) 63 (47.7%) 158 (39.5%)
#> trm A_2/2 48 (35.8%) 48 (35.8%) 50 (37.9%) 146 (36.5%)
#> cl B
#> Total number of patients with at least one condition 96 (71.6%) 89 (66.4%) 97 (73.5%) 282 (70.5%)
#> Total number of conditions 185 198 205 588
#> trm B_3/3 48 (35.8%) 54 (40.3%) 51 (38.6%) 153 (38.2%)
#> trm B_2/3 49 (36.6%) 44 (32.8%) 52 (39.4%) 145 (36.2%)
#> trm B_1/3 47 (35.1%) 49 (36.6%) 43 (32.6%) 139 (34.8%)
#> cl C
#> Total number of patients with at least one condition 67 (50.0%) 75 (56.0%) 79 (59.8%) 221 (55.2%)
#> Total number of conditions 103 116 129 348
#> trm C_2/2 35 (26.1%) 48 (35.8%) 55 (41.7%) 138 (34.5%)
#> trm C_1/2 43 (32.1%) 46 (34.3%) 43 (32.6%) 132 (33.0%)
#> cl D
#> Total number of patients with at least one condition 96 (71.6%) 90 (67.2%) 98 (74.2%) 284 (71.0%)
#> Total number of conditions 189 178 209 576
#> trm D_3/3 47 (35.1%) 58 (43.3%) 57 (43.2%) 162 (40.5%)
#> trm D_1/3 50 (37.3%) 42 (31.3%) 51 (38.6%) 143 (35.8%)
#> trm D_2/3 48 (35.8%) 42 (31.3%) 50 (37.9%) 140 (35.0%)
Duration of Exposure for Risk Management Plan
(RMPT01)
1. Duration of Exposure for Risk Management Plan
The rmpt01 template produces the
standard duration of exposure output for the Risk Management Plan
(RMP).
Person time is the sum of exposure across all patients in days.
run(rmpt01, syn_data)
#> Patients Person time
#> Duration of exposure (N=400) (N=400)
#> ——————————————————————————————————————————————————————————————
#> < 1 month 39 (9.8%) 728
#> 1 to <3 months 111 (27.8%) 6418
#> 3 to <6 months 136 (34.0%) 17645
#> >=6 months 114 (28.5%) 24909
#> Total patients number/person time 400 (100.0%) 49700
Extent of Exposure by Age Group and Gender for Risk
Management Plan (RMPT03)
1. Extent of Exposure by Age Group and Gender for Risk Management Plan
The rmpt03 template produces the
standard extent of exposure by age group and gender output for the Risk
Management Plan (RMP).
By default, the AGEGR1 variable is used as the age
group. If AGEGR1 is available in ADSL only but
not in ADEX, it needs to be added to ADEX
first.
proc_data <- syn_data
proc_data <- propagate(proc_data, "adsl", "AGEGR1", "USUBJID")
#>
#> Updating: adab with: AGEGR1
#> Updating: adae with: AGEGR1
#> Updating: adaette with: AGEGR1
#> Updating: adcm with: AGEGR1
#> Updating: addv with: AGEGR1
#> Updating: adeg with: AGEGR1
#> Updating: adex with: AGEGR1
#> Updating: adhy with: AGEGR1
#> Updating: adlb with: AGEGR1
#> Updating: admh with: AGEGR1
#> Updating: adpc with: AGEGR1
#> Updating: adpp with: AGEGR1
#> Updating: adqs with: AGEGR1
#> Skipping: adrs
#> Updating: adsub with: AGEGR1
#> Skipping: adtr
#> Skipping: adtte
#> Updating: advs with: AGEGR1
run(rmpt03, proc_data)
#> All Genders F M
#> Age Group Patients Person time Patients Person time Patients Person time
#> (N=400) (N=400) (N=231) (N=231) (N=169) (N=169)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> <65 399 (99.8%) 49488 231 (100.0%) 27364 168 (99.4%) 22124
#> >=65 1 (0.2%) 212 0 (0.0%) 0 1 (0.6%) 212
#> Total patients number/person time 400 (100.0%) 49700 231 (100.0%) 27364 169 (100.0%) 22336Any other study specific age group can be used by editing the
parameter summaryvars. For all RMP tables, if
the variable specified per summaryvars is unavailable in
ADEX, it needs to be added to ADEX first.
proc_data <- syn_data
proc_data$adsl <- proc_data$adsl %>%
mutate(
AGEGR2 = with_label(
factor(case_when(
AAGE < 18 ~ "<18",
AAGE >= 18 & AAGE <= 65 ~ "18 - 65",
AAGE > 65 ~ ">65",
), levels = c("<18", "18 - 65", ">65")),
"Age Group 2"
)
)
proc_data <- propagate(proc_data, "adsl", "AGEGR2", "USUBJID")
#>
#> Updating: adab with: AGEGR2
#> Updating: adae with: AGEGR2
#> Updating: adaette with: AGEGR2
#> Updating: adcm with: AGEGR2
#> Updating: addv with: AGEGR2
#> Updating: adeg with: AGEGR2
#> Updating: adex with: AGEGR2
#> Updating: adhy with: AGEGR2
#> Updating: adlb with: AGEGR2
#> Updating: admh with: AGEGR2
#> Updating: adpc with: AGEGR2
#> Updating: adpp with: AGEGR2
#> Updating: adqs with: AGEGR2
#> Updating: adrs with: AGEGR2
#> Updating: adsub with: AGEGR2
#> Updating: adtr with: AGEGR2
#> Updating: adtte with: AGEGR2
#> Updating: advs with: AGEGR2
run(rmpt03, proc_data, summaryvars = "AGEGR2")
#> All Genders F M
#> Age Group 2 Patients Person time Patients Person time Patients Person time
#> (N=400) (N=400) (N=231) (N=231) (N=169) (N=169)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> <18 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0
#> 18 - 65 399 (99.8%) 49488 231 (100.0%) 27364 168 (99.4%) 22124
#> >65 1 (0.2%) 212 0 (0.0%) 0 1 (0.6%) 212
#> Total patients number/person time 400 (100.0%) 49700 231 (100.0%) 27364 169 (100.0%) 22336
Extent of Exposure by Ethnic Origin for Risk Management Plan
(RMPT04)
1. Extent of Exposure by Ethnic Origin for Risk Management Plan
The rmpt04 template produces the
standard extent of exposure by ethnic origin output for the Risk
Management Plan (RMP).
run(rmpt04, syn_data)
#> Patients Person time
#> ETHNIC (N=400) (N=400)
#> ——————————————————————————————————————————————————————————————
#> NOT REPORTED 27 (6.8%) 3315
#> HISPANIC OR LATINO 48 (12.0%) 4636
#> NOT HISPANIC OR LATINO 308 (77.0%) 39229
#> UNKNOWN 17 (4.2%) 2520
#> Total patients number/person time 400 (100.0%) 49700
Extent of Exposure by Race for Risk Management Plan
(RMPT05)
1. Extent of Exposure by Race for Risk Management Plan
The rmpt05 template produces the
standard extent of exposure by race output for the Risk Management Plan
(RMP).
run(rmpt05, syn_data)
#> Patients Person time
#> RACE (N=400) (N=400)
#> ——————————————————————————————————————————————————————————————————————
#> ASIAN 208 (52.0%) 25754
#> BLACK OR AFRICAN AMERICAN 91 (22.8%) 10718
#> WHITE 74 (18.5%) 9612
#> AMERICAN INDIAN OR ALASKA NATIVE 25 (6.2%) 3348
#> MULTIPLE 1 (0.2%) 219
#> NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 1 (0.2%) 49
#> OTHER 0 (0.0%) 0
#> UNKNOWN 0 (0.0%) 0
#> Total patients number/person time 400 (100.0%) 49700
Vital Signs (VST01)
1. Vital Sign Results and Change from Baseline by Visit
t_vs_chg <- run(vst01, syn_data)
head(t_vs_chg, 20)
#> A: Drug X B: Placebo C: Combination
#> Change from Change from Change from
#> Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline
#> (N=134) (N=134) (N=134) (N=134) (N=132) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Diastolic Blood Pressure
#> SCREENING
#> n 134 0 134 0 132 0
#> Mean (SD) 49.968 (7.197) NE (NE) 50.753 (8.429) NE (NE) 50.192 (7.627) NE (NE)
#> Median 49.706 NE 50.087 NE 49.641 NE
#> Min - Max 31.69 - 71.19 NE - NE 29.26 - 69.21 NE - NE 26.89 - 69.98 NE - NE
#> BASELINE
#> n 134 134 132
#> Mean (SD) 48.602 (7.962) 50.442 (7.948) 51.107 (7.790)
#> Median 48.418 50.179 50.804
#> Min - Max 27.71 - 64.64 21.68 - 67.51 29.75 - 71.40
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 50.260 (7.514) 1.658 (10.774) 49.674 (7.743) -0.767 (10.947) 48.855 (7.888) -2.251 (10.380)
#> Median 50.088 0.607 49.747 -1.114 47.677 -2.229
#> Min - Max 33.04 - 68.98 -20.37 - 29.94 33.71 - 66.49 -25.80 - 28.37 30.39 - 66.99 -22.06 - 22.44
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 50.836 (7.850) 2.234 (11.752) 49.718 (8.445) -0.724 (12.444) 49.981 (8.338) -1.126 (11.639)
#> Median 51.437 3.126 50.227 -0.709 51.007 -2.271
Vital Signs Abnormalities (Regardless of Abnormality at
Baseline) (VST02_1)
1. Vital Sign Abnormalities (Regardless of Abnormality at Baseline)
run(vst02_1, syn_data)
#> Assessment A: Drug X B: Placebo C: Combination
#> Abnormality (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————
#> Diastolic Blood Pressure
#> Low 69/134 (51.5%) 73/134 (54.5%) 67/132 (50.8%)
#> High 76/134 (56.7%) 67/134 (50%) 65/132 (49.2%)
#> Pulse Rate
#> Low 75/134 (56%) 67/134 (50%) 69/132 (52.3%)
#> High 67/134 (50%) 74/134 (55.2%) 53/132 (40.2%)
#> Respiratory Rate
#> Low 70/134 (52.2%) 72/134 (53.7%) 64/132 (48.5%)
#> High 75/134 (56%) 65/134 (48.5%) 71/132 (53.8%)
#> Systolic Blood Pressure
#> Low 71/134 (53%) 69/134 (51.5%) 70/132 (53%)
#> High 78/134 (58.2%) 62/134 (46.3%) 64/132 (48.5%)
#> Temperature
#> Low 66/134 (49.3%) 68/134 (50.7%) 81/132 (61.4%)
#> High 67/134 (50%) 66/134 (49.3%) 69/132 (52.3%)
#> Weight
#> Low 73/134 (54.5%) 71/134 (53%) 76/132 (57.6%)
#> High 69/134 (51.5%) 74/134 (55.2%) 74/132 (56.1%)
Vital Signs Abnormalities (Among Subject Without Abnormality
at Baseline) (VST02_2)
1. Vital Sign Abnormalities (Among Subject Without Abnormality at Baseline)
run(vst02_2, syn_data)
#> Assessment A: Drug X B: Placebo C: Combination
#> Abnormality (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————
#> Diastolic Blood Pressure
#> Low 55/120 (45.8%) 60/121 (49.6%) 53/118 (44.9%)
#> High 55/113 (48.7%) 56/123 (45.5%) 52/119 (43.7%)
#> Pulse Rate
#> Low 66/125 (52.8%) 54/121 (44.6%) 55/118 (46.6%)
#> High 52/119 (43.7%) 59/119 (49.6%) 38/117 (32.5%)
#> Respiratory Rate
#> Low 59/123 (48%) 56/118 (47.5%) 50/118 (42.4%)
#> High 65/124 (52.4%) 58/127 (45.7%) 57/118 (48.3%)
#> Systolic Blood Pressure
#> Low 53/116 (45.7%) 55/120 (45.8%) 58/120 (48.3%)
#> High 65/121 (53.7%) 53/125 (42.4%) 56/124 (45.2%)
#> Temperature
#> Low 51/119 (42.9%) 53/119 (44.5%) 64/115 (55.7%)
#> High 61/128 (47.7%) 53/121 (43.8%) 59/122 (48.4%)
#> Weight
#> Low 59/120 (49.2%) 54/117 (46.2%) 63/119 (52.9%)
#> High 58/123 (47.2%) 61/121 (50.4%) 55/113 (48.7%)LISTINGS
Glossary of Adverse Event Preferred Terms and
Investigator-Specified Terms (AEL01_NOLLT)
1. Glossary of Adverse Event Preferred Terms and Investigator-Specified Terms
- The
ael01_nollttemplate produces the standard glossary of adverse event preferred terms and investigator-specified terms. - The example below use
headfunction to print only the first 10 lines of the output.
l_ae_nollt <- run(ael01_nollt, syn_data)
head(l_ae_nollt, 10)
#> MedDRA System Organ Class MedDRA Preferred Term Reported Term for the Adverse Event
#> ———————————————————————————————————————————————————————————————————————————————————————
#> cl A.1 dcd A.1.1.1.1 trm A.1.1.1.1
#> dcd A.1.1.1.2 trm A.1.1.1.2
#> cl B.1 dcd B.1.1.1.1 trm B.1.1.1.1
#> cl B.2 dcd B.2.1.2.1 trm B.2.1.2.1
#> dcd B.2.2.3.1 trm B.2.2.3.1
#> cl C.1 dcd C.1.1.1.3 trm C.1.1.1.3
#> cl C.2 dcd C.2.1.2.1 trm C.2.1.2.1
#> cl D.1 dcd D.1.1.1.1 trm D.1.1.1.1
#> dcd D.1.1.4.2 trm D.1.1.4.2
#> cl D.2 dcd D.2.1.5.3 trm D.2.1.5.3