chevron:
Standard TLGs for clinical trials reporting (original) (raw)
chevron is a collection of high-level functions to create standard outputs for clinical trials reporting with limited parameterisation. These outputs includes:
- Tables:
- safety table, e.g.
* Safety Summary (AET01) - adverse events table, e.g.
* Adverse Events (AET02)
* Adverse Events by Greatest Intensity (AET03)
* Most Common (>=5%) Adverse Events (AET10) - demographic table, e.g.
* Demographics and Baseline Characteristics (DMT01) - ECG table, e.g.
* ECG Results and Change from Baseline by Visit (EGT01)
* ECG Abnormalities (Regardless of Abnormality at Baseline) (EGT02_1)
* ECG Abnormalities (Among Subject Without Abnormality at Baseline) (EGT02_2) - lab results table, e.g.
* Laboratory Test Results and Change from Baseline by Visit (LBT01)
* Laboratory Abnormalities (LBT04)
* Laboratory Abnormalities with Single and Replicated Marked (LBT05) - medical history table, e.g.
* Medical History (MHT01) - response table, e.g.
* Best Overall Response (RSPT01) - time to event table, e.g.
* Time-to-event Summary (TTET01) - vital signs, e.g.
* Vital Signs (VST01)
* Vital Signs Abnormalities (Regardless of Abnormality at Baseline) (VST02_1)
* Vital Signs Abnormalities (Among Subject Without Abnormality at Baseline) (VST02_2)
- safety table, e.g.
- Listings
- Graphs:
Please visit the catalog to see full list of available outputs. If you want a new output, please create an issue.
If you need more flexibility please refer to ternwith its TLG Catalog.
Installation
chevron is available on CRAN and you can install the latest released version with:
install.packages("chevron")Alternatively, you might also use the development version.
# install.packages("pak")
pak::pak("insightsengineering/chevron")Usage
To understand how to use this package, please refer to the Introduction to chevron article, which provides multiple examples of code implementation.
Below is the showcase of the example usage.
library(chevron)
data(syn_data)
run(aet02, syn_data)which returns
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 adverse event 122 (91.0%) 123 (91.8%) 120 (90.9%)
Overall total number of events 609 622 703
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%)Acknowledgment
This package is a result of a joint efforts by many developers and stakeholders. We would like to thank everyone who has contributed so far!
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