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tests/testthat/_snaps/default_tlg.md
In chevron: Standard TLGs for Clinical Trials Reporting
ael01_nollt function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
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
aet01 function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
(N=15) (N=15) (N=15)
—————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 13 (86.7%) 14 (93.3%) 15 (100%)
Total number of AEs 58 59 99
Total number of deaths 2 (13.3%) 4 (26.7%) 3 (20.0%)
Total number of patients withdrawn from study due to an AE 0 0 1 (6.7%)
Total number of patients with at least one
AE with fatal outcome 8 (53.3%) 8 (53.3%) 10 (66.7%)
Serious AE 12 (80.0%) 12 (80.0%) 11 (73.3%)
Serious AE leading to withdrawal from treatment 0 0 2 (13.3%)
Serious AE leading to dose modification/interruption 4 (26.7%) 3 (20.0%) 4 (26.7%)
Related Serious AE 8 (53.3%) 8 (53.3%) 10 (66.7%)
AE leading to withdrawal from treatment 2 (13.3%) 3 (20.0%) 3 (20.0%)
AE leading to dose modification/interruption 6 (40.0%) 9 (60.0%) 11 (73.3%)
Related AE 11 (73.3%) 10 (66.7%) 13 (86.7%)
Related AE leading to withdrawal from treatment 0 3 (20.0%) 0
Related AE leading to dose modification/interruption 1 (6.7%) 4 (26.7%) 9 (60.0%)
Severe AE (at greatest intensity) 11 (73.3%) 10 (66.7%) 12 (80.0%)
aet01_aesi function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 13 (86.7%) 14 (93.3%)
Total number of AEs 58 59
Total number of patients with at least one AE by worst grade
Grade 1 0 1 (6.7%)
Grade 2 1 (6.7%) 1 (6.7%)
Grade 3 1 (6.7%) 2 (13.3%)
Grade 4 3 (20.0%) 2 (13.3%)
Grade 5 (fatal outcome) 8 (53.3%) 8 (53.3%)
Total number of patients with study drug withdrawn due to AE 2 (13.3%) 3 (20.0%)
Total number of patients with dose modified/interrupted due to AE 6 (40.0%) 9 (60.0%)
Total number of patients with treatment received for AE 10 (66.7%) 10 (66.7%)
Total number of patients with all non-fatal AEs resolved 9 (60.0%) 10 (66.7%)
Total number of patients with at least one unresolved or ongoing non-fatal AE 10 (66.7%) 9 (60.0%)
Total number of patients with at least one serious AE 12 (80.0%) 12 (80.0%)
Total number of patients with at least one related AE 11 (73.3%) 10 (66.7%)
\s\n C: Combination
(N=15)
——————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 15 (100%)
Total number of AEs 99
Total number of patients with at least one AE by worst grade
Grade 1 1 (6.7%)
Grade 2 1 (6.7%)
Grade 3 1 (6.7%)
Grade 4 2 (13.3%)
Grade 5 (fatal outcome) 10 (66.7%)
Total number of patients with study drug withdrawn due to AE 3 (20.0%)
Total number of patients with dose modified/interrupted due to AE 11 (73.3%)
Total number of patients with treatment received for AE 14 (93.3%)
Total number of patients with all non-fatal AEs resolved 12 (80.0%)
Total number of patients with at least one unresolved or ongoing non-fatal AE 14 (93.3%)
Total number of patients with at least one serious AE 11 (73.3%)
Total number of patients with at least one related AE 13 (86.7%)
aet02 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
—————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one adverse event 13 (86.7%) 14 (93.3%) 15 (100%)
Overall total number of events 58 59 99
cl B.2
Total number of patients with at least one adverse event 11 (73.3%) 8 (53.3%) 10 (66.7%)
Total number of events 18 15 20
dcd B.2.2.3.1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
Total number of patients with at least one adverse event 9 (60.0%) 5 (33.3%) 11 (73.3%)
Total number of events 13 9 19
dcd D.1.1.1.1 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
Total number of patients with at least one adverse event 7 (46.7%) 6 (40.0%) 10 (66.7%)
Total number of events 8 11 16
dcd A.1.1.1.2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
Total number of patients with at least one adverse event 5 (33.3%) 6 (40.0%) 8 (53.3%)
Total number of events 6 6 12
dcd B.1.1.1.1 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
Total number of patients with at least one adverse event 6 (40.0%) 4 (26.7%) 8 (53.3%)
Total number of events 6 4 12
dcd C.2.1.2.1 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
Total number of patients with at least one adverse event 2 (13.3%) 5 (33.3%) 7 (46.7%)
Total number of events 3 5 10
dcd D.2.1.5.3 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
Total number of patients with at least one adverse event 4 (26.7%) 4 (26.7%) 5 (33.3%)
Total number of events 4 9 10
dcd C.1.1.1.3 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet03 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————————
- Any Intensity - 13 (86.7%) 14 (93.3%) 15 (100%)
MILD 0 1 (6.7%) 1 (6.7%)
MODERATE 2 (13.3%) 3 (20.0%) 2 (13.3%)
SEVERE 11 (73.3%) 10 (66.7%) 12 (80.0%)
cl B.2
- Any Intensity - 11 (73.3%) 8 (53.3%) 10 (66.7%)
MILD 6 (40.0%) 2 (13.3%) 5 (33.3%)
MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd B.2.2.3.1
- Any Intensity - 8 (53.3%) 6 (40.0%) 7 (46.7%)
MILD 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 5 (33.3%)
MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
- Any Intensity - 9 (60.0%) 5 (33.3%) 11 (73.3%)
MODERATE 5 (33.3%) 1 (6.7%) 4 (26.7%)
SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.1.1
- Any Intensity - 4 (26.7%) 4 (26.7%) 7 (46.7%)
SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2
- Any Intensity - 6 (40.0%) 2 (13.3%) 7 (46.7%)
MODERATE 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
- Any Intensity - 7 (46.7%) 6 (40.0%) 10 (66.7%)
MILD 2 (13.3%) 0 4 (26.7%)
MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.2
- Any Intensity - 5 (33.3%) 6 (40.0%) 6 (40.0%)
MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1
- Any Intensity - 3 (20.0%) 1 (6.7%) 6 (40.0%)
MILD 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd B.1.1.1.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
- Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd C.2.1.2.1
- Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
- Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd D.2.1.5.3
- Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
- Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd C.1.1.1.3
- Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet04 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class
MedDRA Preferred Term A: Drug X B: Placebo C: Combination
Grade (N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————————————————————————
- Any adverse events -
- Any Grade - 13 (86.7%) 14 (93.3%) 15 (100%)
Grade 1-2 1 (6.7%) 2 (13.3%) 2 (13.3%)
1 0 1 (6.7%) 1 (6.7%)
2 1 (6.7%) 1 (6.7%) 1 (6.7%)
Grade 3-4 4 (26.7%) 4 (26.7%) 3 (20.0%)
3 1 (6.7%) 2 (13.3%) 1 (6.7%)
4 3 (20.0%) 2 (13.3%) 2 (13.3%)
Grade 5 8 (53.3%) 8 (53.3%) 10 (66.7%)
cl B.2
- Overall -
- Any Grade - 11 (73.3%) 8 (53.3%) 10 (66.7%)
Grade 1-2 6 (40.0%) 2 (13.3%) 5 (33.3%)
1 6 (40.0%) 2 (13.3%) 5 (33.3%)
Grade 3-4 5 (33.3%) 6 (40.0%) 5 (33.3%)
3 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd B.2.2.3.1
- Any Grade - 8 (53.3%) 6 (40.0%) 7 (46.7%)
Grade 1-2 8 (53.3%) 6 (40.0%) 7 (46.7%)
1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1
- Any Grade - 5 (33.3%) 6 (40.0%) 5 (33.3%)
Grade 3-4 5 (33.3%) 6 (40.0%) 5 (33.3%)
3 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
- Overall -
- Any Grade - 9 (60.0%) 5 (33.3%) 11 (73.3%)
Grade 3-4 5 (33.3%) 1 (6.7%) 4 (26.7%)
3 5 (33.3%) 1 (6.7%) 4 (26.7%)
Grade 5 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.1.1
- Any Grade - 4 (26.7%) 4 (26.7%) 7 (46.7%)
Grade 5 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2
- Any Grade - 6 (40.0%) 2 (13.3%) 7 (46.7%)
Grade 3-4 6 (40.0%) 2 (13.3%) 7 (46.7%)
3 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
- Overall -
- Any Grade - 7 (46.7%) 6 (40.0%) 10 (66.7%)
Grade 1-2 7 (46.7%) 6 (40.0%) 10 (66.7%)
1 2 (13.3%) 0 4 (26.7%)
2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.2
- Any Grade - 5 (33.3%) 6 (40.0%) 6 (40.0%)
Grade 1-2 5 (33.3%) 6 (40.0%) 6 (40.0%)
2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1
- Any Grade - 3 (20.0%) 1 (6.7%) 6 (40.0%)
Grade 1-2 3 (20.0%) 1 (6.7%) 6 (40.0%)
1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
- Overall -
- Any Grade - 5 (33.3%) 6 (40.0%) 8 (53.3%)
Grade 5 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd B.1.1.1.1
- Any Grade - 5 (33.3%) 6 (40.0%) 8 (53.3%)
Grade 5 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
- Overall -
- Any Grade - 6 (40.0%) 4 (26.7%) 8 (53.3%)
Grade 1-2 6 (40.0%) 4 (26.7%) 8 (53.3%)
2 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd C.2.1.2.1
- Any Grade - 6 (40.0%) 4 (26.7%) 8 (53.3%)
Grade 1-2 6 (40.0%) 4 (26.7%) 8 (53.3%)
2 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
- Overall -
- Any Grade - 2 (13.3%) 5 (33.3%) 7 (46.7%)
Grade 1-2 2 (13.3%) 5 (33.3%) 7 (46.7%)
1 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd D.2.1.5.3
- Any Grade - 2 (13.3%) 5 (33.3%) 7 (46.7%)
Grade 1-2 2 (13.3%) 5 (33.3%) 7 (46.7%)
1 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
- Overall -
- Any Grade - 4 (26.7%) 4 (26.7%) 5 (33.3%)
Grade 3-4 4 (26.7%) 4 (26.7%) 5 (33.3%)
4 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd C.1.1.1.3
- Any Grade - 4 (26.7%) 4 (26.7%) 5 (33.3%)
Grade 3-4 4 (26.7%) 4 (26.7%) 5 (33.3%)
4 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet05 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
——————————————————————————————————————————————————————————————————————————————————————————
Time to first occurrence of a grade 3-5 adverse event
Total patient-years at risk 10.3 6.3
Number of adverse events observed 12 14
AE rate per 100 patient-years 116.36 223.74
95% CI (50.53, 182.20) (106.54, 340.94)
Time to first occurrence of any adverse event
Total patient-years at risk 31.0 9.0
Number of adverse events observed 5 13
AE rate per 100 patient-years 16.13 143.75
95% CI (1.99, 30.27) (65.61, 221.89)
Time to first occurrence of any serious adverse event
Total patient-years at risk 32.9 7.6
Number of adverse events observed 4 14
AE rate per 100 patient-years 12.15 183.83
95% CI (0.24, 24.05) (87.53, 280.12)
\s\n C: Combination
(N=15)
———————————————————————————————————————————————————————————————————————
Time to first occurrence of a grade 3-5 adverse event
Total patient-years at risk 8.3
Number of adverse events observed 13
AE rate per 100 patient-years 156.98
95% CI (71.65, 242.32)
Time to first occurrence of any adverse event
Total patient-years at risk 22.0
Number of adverse events observed 8
AE rate per 100 patient-years 36.30
95% CI (11.15, 61.45)
Time to first occurrence of any serious adverse event
Total patient-years at risk 9.4
Number of adverse events observed 13
AE rate per 100 patient-years 137.79
95% CI (62.89, 212.68)
aet05_all functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————
Number of occurrences of a grade 3-5 adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 65 54
AE rate per 100 patient-years 146.40 122.06
95% CI (110.81, 181.99) (89.50, 154.61)
Number of occurrences of any adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 29 49
AE rate per 100 patient-years 65.32 110.76
95% CI (41.54, 89.09) (79.75, 141.77)
Number of occurrences of any serious adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 9 36
AE rate per 100 patient-years 20.27 81.37
95% CI (7.03, 33.51) (54.79, 107.95)
\s\n C: Combination
(N=15)
—————————————————————————————————————————————————————————————————————
Number of occurrences of a grade 3-5 adverse event
Total patient-years at risk 44.4
Number of adverse events observed 95
AE rate per 100 patient-years 214.00
95% CI (170.97, 257.04)
Number of occurrences of any adverse event
Total patient-years at risk 44.4
Number of adverse events observed 56
AE rate per 100 patient-years 126.15
95% CI (93.11, 159.19)
Number of occurrences of any serious adverse event
Total patient-years at risk 44.4
Number of adverse events observed 60
AE rate per 100 patient-years 135.16
95% CI (100.96, 169.36)
aet10 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
———————————————————————————————————————————————————————————————
dcd B.2.2.3.1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.1.1.1.1 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd C.2.1.2.1 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd A.1.1.1.2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd B.2.1.2.1 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd D.1.1.1.1 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2 6 (40.0%) 2 (13.3%) 7 (46.7%)
dcd D.2.1.5.3 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd C.1.1.1.3 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd A.1.1.1.1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cmt02_pt functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
Other Treatment (N=15) (N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one treatment 13 (86.7%) 14 (93.3%) 15 (100%)
Total number of treatments 58 59 99
medname B_3/4 8 (53.3%) 6 (40.0%) 8 (53.3%)
medname B_2/4 6 (40.0%) 5 (33.3%) 10 (66.7%)
medname A_3/3 5 (33.3%) 8 (53.3%) 6 (40.0%)
medname B_1/4 7 (46.7%) 6 (40.0%) 6 (40.0%)
medname A_2/3 5 (33.3%) 6 (40.0%) 7 (46.7%)
medname B_4/4 4 (26.7%) 5 (33.3%) 8 (53.3%)
medname C_2/2 4 (26.7%) 5 (33.3%) 7 (46.7%)
medname A_1/3 4 (26.7%) 3 (20.0%) 8 (53.3%)
medname C_1/2 6 (40.0%) 2 (13.3%) 6 (40.0%)
coxt01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
Treatment Effect Adjusted for Covariate
Effect/Covariate Included in the Model n Hazard Ratio 95% CI p-value
—————————————————————————————————————————————————————————————————————————————————————————
Treatment:
B: Placebo vs control (A: Drug X) 30 0.68 (0.25, 1.89) 0.4638
Covariate:
Sex 30 0.53 (0.18, 1.58) 0.2553
RACE 30 0.79 (0.28, 2.17) 0.6415
Age (yr) 30 0.67 (0.24, 1.89) 0.4526
coxt02 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
Effect/Covariate Included in the Model Hazard Ratio 95% CI p-value
——————————————————————————————————————————————————————————————————————————————————————————————
Treatment:
Description of Planned Arm (reference = A: Drug X) 0.6859
B: Placebo 0.77 (0.29, 2.08) 0.6113
C: Combination 0.62 (0.21, 1.82) 0.3853
Covariate:
Sex (reference = F)
M 1.41 (0.61, 3.23) 0.4194
RACE (reference = AMERICAN INDIAN OR ALASKA NATIVE) 0.8938
ASIAN 1.69 (0.36, 7.99) 0.5055
BLACK OR AFRICAN AMERICAN 1.86 (0.29, 11.72) 0.5109
WHITE 2.03 (0.34, 12.25) 0.4414
Age (yr)
All 1.00 (0.94, 1.08) 0.8951
dmt01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination All Patients
(N=15) (N=15) (N=15) (N=45)
————————————————————————————————————————————————————————————————————————————————————————————
Age (yr)
n 15 15 15 45
Mean (SD) 31.3 (5.3) 35.1 (9.0) 36.6 (6.4) 34.3 (7.3)
Median 31.0 35.0 35.0 34.0
Min - Max 24 - 40 24 - 57 24 - 49 24 - 57
Age Group
n 15 15 15 45
<65 15 (100%) 15 (100%) 15 (100%) 45 (100%)
Sex
n 15 15 15 45
Male 3 (20.0%) 7 (46.7%) 5 (33.3%) 15 (33.3%)
Female 12 (80.0%) 8 (53.3%) 10 (66.7%) 30 (66.7%)
Ethnicity
n 15 15 15 45
HISPANIC OR LATINO 2 (13.3%) 0 0 2 (4.4%)
NOT HISPANIC OR LATINO 13 (86.7%) 15 (100%) 13 (86.7%) 41 (91.1%)
NOT REPORTED 0 0 2 (13.3%) 2 (4.4%)
RACE
n 15 15 15 45
AMERICAN INDIAN OR ALASKA NATIVE 0 2 (13.3%) 1 (6.7%) 3 (6.7%)
ASIAN 8 (53.3%) 10 (66.7%) 8 (53.3%) 26 (57.8%)
BLACK OR AFRICAN AMERICAN 4 (26.7%) 1 (6.7%) 4 (26.7%) 9 (20.0%)
WHITE 3 (20.0%) 2 (13.3%) 2 (13.3%) 7 (15.6%)
dst01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination All Patients
(N=15) (N=15) (N=15) (N=45)
—————————————————————————————————————————————————————————————————————————————————————————
Completed 10 (66.7%) 10 (66.7%) 10 (66.7%) 30 (66.7%)
Discontinued 5 (33.3%) 5 (33.3%) 5 (33.3%) 15 (33.3%)
ADVERSE EVENT 0 0 1 (6.7%) 1 (2.2%)
DEATH 2 (13.3%) 4 (26.7%) 3 (20.0%) 9 (20.0%)
LACK OF EFFICACY 2 (13.3%) 0 0 2 (4.4%)
PHYSICIAN DECISION 0 0 1 (6.7%) 1 (2.2%)
PROTOCOL VIOLATION 0 1 (6.7%) 0 1 (2.2%)
WITHDRAWAL BY PARENT/GUARDIAN 1 (6.7%) 0 0 1 (2.2%)
dtht01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
(N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————
Total number of deaths 2 (13.3%) 4 (26.7%) 3 (20.0%)
Primary Cause of Death
n 2 4 3
Adverse Event 1 (50.0%) 2 (50.0%) 1 (33.3%)
Progressive Disease 1 (50.0%) 0 2 (66.7%)
Other 0 2 (50.0%) 0
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ael01_nollt function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
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
aet01 function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
(N=15) (N=15) (N=15)
—————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 13 (86.7%) 14 (93.3%) 15 (100%)
Total number of AEs 58 59 99
Total number of deaths 2 (13.3%) 4 (26.7%) 3 (20.0%)
Total number of patients withdrawn from study due to an AE 0 0 1 (6.7%)
Total number of patients with at least one
AE with fatal outcome 8 (53.3%) 8 (53.3%) 10 (66.7%)
Serious AE 12 (80.0%) 12 (80.0%) 11 (73.3%)
Serious AE leading to withdrawal from treatment 0 0 2 (13.3%)
Serious AE leading to dose modification/interruption 4 (26.7%) 3 (20.0%) 4 (26.7%)
Related Serious AE 8 (53.3%) 8 (53.3%) 10 (66.7%)
AE leading to withdrawal from treatment 2 (13.3%) 3 (20.0%) 3 (20.0%)
AE leading to dose modification/interruption 6 (40.0%) 9 (60.0%) 11 (73.3%)
Related AE 11 (73.3%) 10 (66.7%) 13 (86.7%)
Related AE leading to withdrawal from treatment 0 3 (20.0%) 0
Related AE leading to dose modification/interruption 1 (6.7%) 4 (26.7%) 9 (60.0%)
Severe AE (at greatest intensity) 11 (73.3%) 10 (66.7%) 12 (80.0%)
aet01_aesi function with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 13 (86.7%) 14 (93.3%)
Total number of AEs 58 59
Total number of patients with at least one AE by worst grade
Grade 1 0 1 (6.7%)
Grade 2 1 (6.7%) 1 (6.7%)
Grade 3 1 (6.7%) 2 (13.3%)
Grade 4 3 (20.0%) 2 (13.3%)
Grade 5 (fatal outcome) 8 (53.3%) 8 (53.3%)
Total number of patients with study drug withdrawn due to AE 2 (13.3%) 3 (20.0%)
Total number of patients with dose modified/interrupted due to AE 6 (40.0%) 9 (60.0%)
Total number of patients with treatment received for AE 10 (66.7%) 10 (66.7%)
Total number of patients with all non-fatal AEs resolved 9 (60.0%) 10 (66.7%)
Total number of patients with at least one unresolved or ongoing non-fatal AE 10 (66.7%) 9 (60.0%)
Total number of patients with at least one serious AE 12 (80.0%) 12 (80.0%)
Total number of patients with at least one related AE 11 (73.3%) 10 (66.7%)
\s\n C: Combination
(N=15)
——————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 15 (100%)
Total number of AEs 99
Total number of patients with at least one AE by worst grade
Grade 1 1 (6.7%)
Grade 2 1 (6.7%)
Grade 3 1 (6.7%)
Grade 4 2 (13.3%)
Grade 5 (fatal outcome) 10 (66.7%)
Total number of patients with study drug withdrawn due to AE 3 (20.0%)
Total number of patients with dose modified/interrupted due to AE 11 (73.3%)
Total number of patients with treatment received for AE 14 (93.3%)
Total number of patients with all non-fatal AEs resolved 12 (80.0%)
Total number of patients with at least one unresolved or ongoing non-fatal AE 14 (93.3%)
Total number of patients with at least one serious AE 11 (73.3%)
Total number of patients with at least one related AE 13 (86.7%)
aet02 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
—————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one adverse event 13 (86.7%) 14 (93.3%) 15 (100%)
Overall total number of events 58 59 99
cl B.2
Total number of patients with at least one adverse event 11 (73.3%) 8 (53.3%) 10 (66.7%)
Total number of events 18 15 20
dcd B.2.2.3.1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
Total number of patients with at least one adverse event 9 (60.0%) 5 (33.3%) 11 (73.3%)
Total number of events 13 9 19
dcd D.1.1.1.1 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
Total number of patients with at least one adverse event 7 (46.7%) 6 (40.0%) 10 (66.7%)
Total number of events 8 11 16
dcd A.1.1.1.2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
Total number of patients with at least one adverse event 5 (33.3%) 6 (40.0%) 8 (53.3%)
Total number of events 6 6 12
dcd B.1.1.1.1 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
Total number of patients with at least one adverse event 6 (40.0%) 4 (26.7%) 8 (53.3%)
Total number of events 6 4 12
dcd C.2.1.2.1 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
Total number of patients with at least one adverse event 2 (13.3%) 5 (33.3%) 7 (46.7%)
Total number of events 3 5 10
dcd D.2.1.5.3 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
Total number of patients with at least one adverse event 4 (26.7%) 4 (26.7%) 5 (33.3%)
Total number of events 4 9 10
dcd C.1.1.1.3 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet03 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————————
- Any Intensity - 13 (86.7%) 14 (93.3%) 15 (100%)
MILD 0 1 (6.7%) 1 (6.7%)
MODERATE 2 (13.3%) 3 (20.0%) 2 (13.3%)
SEVERE 11 (73.3%) 10 (66.7%) 12 (80.0%)
cl B.2
- Any Intensity - 11 (73.3%) 8 (53.3%) 10 (66.7%)
MILD 6 (40.0%) 2 (13.3%) 5 (33.3%)
MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd B.2.2.3.1
- Any Intensity - 8 (53.3%) 6 (40.0%) 7 (46.7%)
MILD 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 5 (33.3%)
MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
- Any Intensity - 9 (60.0%) 5 (33.3%) 11 (73.3%)
MODERATE 5 (33.3%) 1 (6.7%) 4 (26.7%)
SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.1.1
- Any Intensity - 4 (26.7%) 4 (26.7%) 7 (46.7%)
SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2
- Any Intensity - 6 (40.0%) 2 (13.3%) 7 (46.7%)
MODERATE 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
- Any Intensity - 7 (46.7%) 6 (40.0%) 10 (66.7%)
MILD 2 (13.3%) 0 4 (26.7%)
MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.2
- Any Intensity - 5 (33.3%) 6 (40.0%) 6 (40.0%)
MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1
- Any Intensity - 3 (20.0%) 1 (6.7%) 6 (40.0%)
MILD 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd B.1.1.1.1
- Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
- Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd C.2.1.2.1
- Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
- Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd D.2.1.5.3
- Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
- Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd C.1.1.1.3
- Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet04 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
MedDRA System Organ Class
MedDRA Preferred Term A: Drug X B: Placebo C: Combination
Grade (N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————————————————————————
- Any adverse events -
- Any Grade - 13 (86.7%) 14 (93.3%) 15 (100%)
Grade 1-2 1 (6.7%) 2 (13.3%) 2 (13.3%)
1 0 1 (6.7%) 1 (6.7%)
2 1 (6.7%) 1 (6.7%) 1 (6.7%)
Grade 3-4 4 (26.7%) 4 (26.7%) 3 (20.0%)
3 1 (6.7%) 2 (13.3%) 1 (6.7%)
4 3 (20.0%) 2 (13.3%) 2 (13.3%)
Grade 5 8 (53.3%) 8 (53.3%) 10 (66.7%)
cl B.2
- Overall -
- Any Grade - 11 (73.3%) 8 (53.3%) 10 (66.7%)
Grade 1-2 6 (40.0%) 2 (13.3%) 5 (33.3%)
1 6 (40.0%) 2 (13.3%) 5 (33.3%)
Grade 3-4 5 (33.3%) 6 (40.0%) 5 (33.3%)
3 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd B.2.2.3.1
- Any Grade - 8 (53.3%) 6 (40.0%) 7 (46.7%)
Grade 1-2 8 (53.3%) 6 (40.0%) 7 (46.7%)
1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.2.1.2.1
- Any Grade - 5 (33.3%) 6 (40.0%) 5 (33.3%)
Grade 3-4 5 (33.3%) 6 (40.0%) 5 (33.3%)
3 5 (33.3%) 6 (40.0%) 5 (33.3%)
cl D.1
- Overall -
- Any Grade - 9 (60.0%) 5 (33.3%) 11 (73.3%)
Grade 3-4 5 (33.3%) 1 (6.7%) 4 (26.7%)
3 5 (33.3%) 1 (6.7%) 4 (26.7%)
Grade 5 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.1.1
- Any Grade - 4 (26.7%) 4 (26.7%) 7 (46.7%)
Grade 5 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2
- Any Grade - 6 (40.0%) 2 (13.3%) 7 (46.7%)
Grade 3-4 6 (40.0%) 2 (13.3%) 7 (46.7%)
3 6 (40.0%) 2 (13.3%) 7 (46.7%)
cl A.1
- Overall -
- Any Grade - 7 (46.7%) 6 (40.0%) 10 (66.7%)
Grade 1-2 7 (46.7%) 6 (40.0%) 10 (66.7%)
1 2 (13.3%) 0 4 (26.7%)
2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.2
- Any Grade - 5 (33.3%) 6 (40.0%) 6 (40.0%)
Grade 1-2 5 (33.3%) 6 (40.0%) 6 (40.0%)
2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd A.1.1.1.1
- Any Grade - 3 (20.0%) 1 (6.7%) 6 (40.0%)
Grade 1-2 3 (20.0%) 1 (6.7%) 6 (40.0%)
1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cl B.1
- Overall -
- Any Grade - 5 (33.3%) 6 (40.0%) 8 (53.3%)
Grade 5 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd B.1.1.1.1
- Any Grade - 5 (33.3%) 6 (40.0%) 8 (53.3%)
Grade 5 5 (33.3%) 6 (40.0%) 8 (53.3%)
cl C.2
- Overall -
- Any Grade - 6 (40.0%) 4 (26.7%) 8 (53.3%)
Grade 1-2 6 (40.0%) 4 (26.7%) 8 (53.3%)
2 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd C.2.1.2.1
- Any Grade - 6 (40.0%) 4 (26.7%) 8 (53.3%)
Grade 1-2 6 (40.0%) 4 (26.7%) 8 (53.3%)
2 6 (40.0%) 4 (26.7%) 8 (53.3%)
cl D.2
- Overall -
- Any Grade - 2 (13.3%) 5 (33.3%) 7 (46.7%)
Grade 1-2 2 (13.3%) 5 (33.3%) 7 (46.7%)
1 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd D.2.1.5.3
- Any Grade - 2 (13.3%) 5 (33.3%) 7 (46.7%)
Grade 1-2 2 (13.3%) 5 (33.3%) 7 (46.7%)
1 2 (13.3%) 5 (33.3%) 7 (46.7%)
cl C.1
- Overall -
- Any Grade - 4 (26.7%) 4 (26.7%) 5 (33.3%)
Grade 3-4 4 (26.7%) 4 (26.7%) 5 (33.3%)
4 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd C.1.1.1.3
- Any Grade - 4 (26.7%) 4 (26.7%) 5 (33.3%)
Grade 3-4 4 (26.7%) 4 (26.7%) 5 (33.3%)
4 4 (26.7%) 4 (26.7%) 5 (33.3%)
aet05 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
——————————————————————————————————————————————————————————————————————————————————————————
Time to first occurrence of a grade 3-5 adverse event
Total patient-years at risk 10.3 6.3
Number of adverse events observed 12 14
AE rate per 100 patient-years 116.36 223.74
95% CI (50.53, 182.20) (106.54, 340.94)
Time to first occurrence of any adverse event
Total patient-years at risk 31.0 9.0
Number of adverse events observed 5 13
AE rate per 100 patient-years 16.13 143.75
95% CI (1.99, 30.27) (65.61, 221.89)
Time to first occurrence of any serious adverse event
Total patient-years at risk 32.9 7.6
Number of adverse events observed 4 14
AE rate per 100 patient-years 12.15 183.83
95% CI (0.24, 24.05) (87.53, 280.12)
\s\n C: Combination
(N=15)
———————————————————————————————————————————————————————————————————————
Time to first occurrence of a grade 3-5 adverse event
Total patient-years at risk 8.3
Number of adverse events observed 13
AE rate per 100 patient-years 156.98
95% CI (71.65, 242.32)
Time to first occurrence of any adverse event
Total patient-years at risk 22.0
Number of adverse events observed 8
AE rate per 100 patient-years 36.30
95% CI (11.15, 61.45)
Time to first occurrence of any serious adverse event
Total patient-years at risk 9.4
Number of adverse events observed 13
AE rate per 100 patient-years 137.79
95% CI (62.89, 212.68)
aet05_all functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo
(N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————
Number of occurrences of a grade 3-5 adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 65 54
AE rate per 100 patient-years 146.40 122.06
95% CI (110.81, 181.99) (89.50, 154.61)
Number of occurrences of any adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 29 49
AE rate per 100 patient-years 65.32 110.76
95% CI (41.54, 89.09) (79.75, 141.77)
Number of occurrences of any serious adverse event
Total patient-years at risk 44.4 44.2
Number of adverse events observed 9 36
AE rate per 100 patient-years 20.27 81.37
95% CI (7.03, 33.51) (54.79, 107.95)
\s\n C: Combination
(N=15)
—————————————————————————————————————————————————————————————————————
Number of occurrences of a grade 3-5 adverse event
Total patient-years at risk 44.4
Number of adverse events observed 95
AE rate per 100 patient-years 214.00
95% CI (170.97, 257.04)
Number of occurrences of any adverse event
Total patient-years at risk 44.4
Number of adverse events observed 56
AE rate per 100 patient-years 126.15
95% CI (93.11, 159.19)
Number of occurrences of any serious adverse event
Total patient-years at risk 44.4
Number of adverse events observed 60
AE rate per 100 patient-years 135.16
95% CI (100.96, 169.36)
aet10 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
MedDRA Preferred Term (N=15) (N=15) (N=15)
———————————————————————————————————————————————————————————————
dcd B.2.2.3.1 8 (53.3%) 6 (40.0%) 7 (46.7%)
dcd B.1.1.1.1 5 (33.3%) 6 (40.0%) 8 (53.3%)
dcd C.2.1.2.1 6 (40.0%) 4 (26.7%) 8 (53.3%)
dcd A.1.1.1.2 5 (33.3%) 6 (40.0%) 6 (40.0%)
dcd B.2.1.2.1 5 (33.3%) 6 (40.0%) 5 (33.3%)
dcd D.1.1.1.1 4 (26.7%) 4 (26.7%) 7 (46.7%)
dcd D.1.1.4.2 6 (40.0%) 2 (13.3%) 7 (46.7%)
dcd D.2.1.5.3 2 (13.3%) 5 (33.3%) 7 (46.7%)
dcd C.1.1.1.3 4 (26.7%) 4 (26.7%) 5 (33.3%)
dcd A.1.1.1.1 3 (20.0%) 1 (6.7%) 6 (40.0%)
cmt02_pt functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
Other Treatment (N=15) (N=15) (N=15)
———————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one treatment 13 (86.7%) 14 (93.3%) 15 (100%)
Total number of treatments 58 59 99
medname B_3/4 8 (53.3%) 6 (40.0%) 8 (53.3%)
medname B_2/4 6 (40.0%) 5 (33.3%) 10 (66.7%)
medname A_3/3 5 (33.3%) 8 (53.3%) 6 (40.0%)
medname B_1/4 7 (46.7%) 6 (40.0%) 6 (40.0%)
medname A_2/3 5 (33.3%) 6 (40.0%) 7 (46.7%)
medname B_4/4 4 (26.7%) 5 (33.3%) 8 (53.3%)
medname C_2/2 4 (26.7%) 5 (33.3%) 7 (46.7%)
medname A_1/3 4 (26.7%) 3 (20.0%) 8 (53.3%)
medname C_1/2 6 (40.0%) 2 (13.3%) 6 (40.0%)
coxt01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
Treatment Effect Adjusted for Covariate
Effect/Covariate Included in the Model n Hazard Ratio 95% CI p-value
—————————————————————————————————————————————————————————————————————————————————————————
Treatment:
B: Placebo vs control (A: Drug X) 30 0.68 (0.25, 1.89) 0.4638
Covariate:
Sex 30 0.53 (0.18, 1.58) 0.2553
RACE 30 0.79 (0.28, 2.17) 0.6415
Age (yr) 30 0.67 (0.24, 1.89) 0.4526
coxt02 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
Effect/Covariate Included in the Model Hazard Ratio 95% CI p-value
——————————————————————————————————————————————————————————————————————————————————————————————
Treatment:
Description of Planned Arm (reference = A: Drug X) 0.6859
B: Placebo 0.77 (0.29, 2.08) 0.6113
C: Combination 0.62 (0.21, 1.82) 0.3853
Covariate:
Sex (reference = F)
M 1.41 (0.61, 3.23) 0.4194
RACE (reference = AMERICAN INDIAN OR ALASKA NATIVE) 0.8938
ASIAN 1.69 (0.36, 7.99) 0.5055
BLACK OR AFRICAN AMERICAN 1.86 (0.29, 11.72) 0.5109
WHITE 2.03 (0.34, 12.25) 0.4414
Age (yr)
All 1.00 (0.94, 1.08) 0.8951
dmt01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination All Patients
(N=15) (N=15) (N=15) (N=45)
————————————————————————————————————————————————————————————————————————————————————————————
Age (yr)
n 15 15 15 45
Mean (SD) 31.3 (5.3) 35.1 (9.0) 36.6 (6.4) 34.3 (7.3)
Median 31.0 35.0 35.0 34.0
Min - Max 24 - 40 24 - 57 24 - 49 24 - 57
Age Group
n 15 15 15 45
<65 15 (100%) 15 (100%) 15 (100%) 45 (100%)
Sex
n 15 15 15 45
Male 3 (20.0%) 7 (46.7%) 5 (33.3%) 15 (33.3%)
Female 12 (80.0%) 8 (53.3%) 10 (66.7%) 30 (66.7%)
Ethnicity
n 15 15 15 45
HISPANIC OR LATINO 2 (13.3%) 0 0 2 (4.4%)
NOT HISPANIC OR LATINO 13 (86.7%) 15 (100%) 13 (86.7%) 41 (91.1%)
NOT REPORTED 0 0 2 (13.3%) 2 (4.4%)
RACE
n 15 15 15 45
AMERICAN INDIAN OR ALASKA NATIVE 0 2 (13.3%) 1 (6.7%) 3 (6.7%)
ASIAN 8 (53.3%) 10 (66.7%) 8 (53.3%) 26 (57.8%)
BLACK OR AFRICAN AMERICAN 4 (26.7%) 1 (6.7%) 4 (26.7%) 9 (20.0%)
WHITE 3 (20.0%) 2 (13.3%) 2 (13.3%) 7 (15.6%)
dst01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination All Patients
(N=15) (N=15) (N=15) (N=45)
—————————————————————————————————————————————————————————————————————————————————————————
Completed 10 (66.7%) 10 (66.7%) 10 (66.7%) 30 (66.7%)
Discontinued 5 (33.3%) 5 (33.3%) 5 (33.3%) 15 (33.3%)
ADVERSE EVENT 0 0 1 (6.7%) 1 (2.2%)
DEATH 2 (13.3%) 4 (26.7%) 3 (20.0%) 9 (20.0%)
LACK OF EFFICACY 2 (13.3%) 0 0 2 (4.4%)
PHYSICIAN DECISION 0 0 1 (6.7%) 1 (2.2%)
PROTOCOL VIOLATION 0 1 (6.7%) 0 1 (2.2%)
WITHDRAWAL BY PARENT/GUARDIAN 1 (6.7%) 0 0 1 (2.2%)
dtht01 functions with default argument value return expected result with test data
Code
cat(export_as_txt(res, lpp = 100))
Output
A: Drug X B: Placebo C: Combination
(N=15) (N=15) (N=15)
————————————————————————————————————————————————————————————————
Total number of deaths 2 (13.3%) 4 (26.7%) 3 (20.0%)
Primary Cause of Death
n 2 4 3
Adverse Event 1 (50.0%) 2 (50.0%) 1 (33.3%)
Progressive Disease 1 (50.0%) 0 2 (66.7%)
Other 0 2 (50.0%) 0
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