|
| 1 | +--- |
| 2 | +engine: knitr |
| 3 | +title: "ADVS" |
| 4 | +--- |
| 5 | + |
| 6 | +# What is BDS? |
| 7 | + |
| 8 | +- **BDS** = Basic Data Structure |
| 9 | +- A flexible ADaM format used for most subject-level analysis datasets |
| 10 | +- Key features: |
| 11 | + - One record per subject, parameter, and timepoint |
| 12 | + - Standardized variables: `PARAMCD`, `AVAL`, `ADY`, `TRTP`, etc. |
| 13 | + - Derived from SDTM + ADSL |
| 14 | + |
| 15 | + |
| 16 | +# Structure |
| 17 | + |
| 18 | +- ADSL variables (Expand ds.) |
| 19 | + |
| 20 | +- Variables kept from SDTM (Dont update values.) |
| 21 | + |
| 22 | +- Common BDS variable (Expand ds. Sometimes Imputations.) |
| 23 | + |
| 24 | + - TRTA/P |
| 25 | + |
| 26 | + - AVISIT |
| 27 | + |
| 28 | + - PARAM |
| 29 | + |
| 30 | + - PARAMCD |
| 31 | + |
| 32 | + - AVAL/AVALC |
| 33 | + |
| 34 | + - BASE |
| 35 | + |
| 36 | + - CHG |
| 37 | + |
| 38 | + - ADT |
| 39 | + |
| 40 | + - ADTM |
| 41 | + |
| 42 | + - ABLFL |
| 43 | + |
| 44 | +# Observations |
| 45 | + |
| 46 | +- Observed values: SDTM data not modified. |
| 47 | + |
| 48 | +- Derived values: Created through calculations of observed values. |
| 49 | + |
| 50 | +- Imputed values: Observed values that have missing portions. These missing portions are supplemented with additional data. |
| 51 | + |
| 52 | +# Updating structure |
| 53 | + |
| 54 | +- A BDS data set can be expanded horizontally with additional derived parameters and vertically with additional analysis variables. |
| 55 | + |
| 56 | +# ADVS |
| 57 | + |
| 58 | +***Vital signs***: parameters related to physiological measurements collected during a clinical trial. |
| 59 | + |
| 60 | +***Examples of Measurements***: |
| 61 | + |
| 62 | +- Blood pressure (systolic/diastolic) |
| 63 | + |
| 64 | +- Heart/pulse rate |
| 65 | + |
| 66 | +- Body temperature |
| 67 | + |
| 68 | +- Respiratory rate |
| 69 | + |
| 70 | +- Height |
| 71 | + |
| 72 | +- Weight |
| 73 | + |
| 74 | +- Body mass index (BMI) |
| 75 | + |
| 76 | +# Mock Table |
| 77 | + |
| 78 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 79 | +| Parameter | | Statistics | Xanomeline | Placebo | P-value | |
| 80 | +| | | | | | | |
| 81 | +| | | | High Dose | | | |
| 82 | ++===========+====================+============+============+==========+==========+ |
| 83 | +| Weight | Baseline | | | | | |
| 84 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 85 | +| | Week 4 | | | | | |
| 86 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 87 | +| | Week 8 | | | | | |
| 88 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 89 | +| | Week 12 | | | | | |
| 90 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 91 | +| | Week 16 | | | | | |
| 92 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 93 | +| | Week 20 | | | | | |
| 94 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 95 | +| | Week 24 | | | | | |
| 96 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 97 | +| | Week 24 - baseline | | | | | |
| 98 | ++-----------+--------------------+------------+------------+----------+----------+ |
| 99 | + |
| 100 | +N = number of subjects in analysis population, n = number of subjects with non-missing observations, nmiss = number of subjects with missing observations, SD = standard deviation, CI = confidence interval, Q1 = first quartile, Q3 = third quartile, Min = minimum, Max = maximum |
| 101 | + |
| 102 | + |
| 103 | +# Hands-On Workshop: BDS – Findings |
| 104 | + |
| 105 | +We will derive a BDS Findings dataset using `{admiral}`. |
| 106 | + |
| 107 | +Link: [https://pharmaverse.github.io/admiral/articles/bds_finding.html](https://pharmaverse.github.io/admiral/articles/bds_finding.html) |
| 108 | + |
| 109 | +Key steps: |
| 110 | +- Read SDTM data |
| 111 | +- Derive `ADT`, `ADY` |
| 112 | +- Assign `PARAMCD`, `PARAM` |
| 113 | +- Derive `AVAL`, `BASE`, `CHG`, etc. |
| 114 | +- Merge with ADSL |
| 115 | +- Add labels and attributes |
| 116 | + |
| 117 | +Repository: [GitHub Code](https://github.com/pharmaverse/admiral/blob/main/vignettes/bds_finding.Rmd) |
| 118 | + |
| 119 | +See recording for the Demo. |
| 120 | + |
| 121 | +# Questions? |
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