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Improved some table layouts
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@SHAESEN2
SHAESEN2 committed Mar 8, 2024
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70 changes: 36 additions & 34 deletions vignettes/adrg.qmd
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Expand Up @@ -5,9 +5,10 @@ format:
pdf:
toc: true
number-sections: true
include-before:
- '`\newpage{}`'
editor: visual
---

{{< pagebreak >}}

# Introduction
Expand Down Expand Up @@ -91,26 +92,26 @@ This was a prospective, randomized, multi-center, double-blind, placebo-controll

Core variables are those that are represented across all/most analysis datasets.

| **Variable Name** | **Variable Description** |
|-------------------|---------------------------------------|
| STUDYID | Study Identifier |
| USUBJID | Unique Subject Identifier |
| SUBJID | Subject Identifier for the Study |
| SITEID | Study Site Identifier |
| SITEGR1 | Pooled Site Group 1 |
| TRTSDT | Date of First Exposure to Treatment |
| TRTEDT | Date of Last Exposure to Treatment |
| AGE | Age |
| AGEGR1 | Pooled Age Group 1 |
| AGEGR1N | Pooled Age Group 1 (N) |
| RACE | Race |
| RACEN | Race (N) |
| SEX | Sex |
| SAFFL | Safety Population Flag |
| ITTFL | Intent-To-Treat Population Flag |
| EFFFL | Efficacy Population Flag |
| COMP24FL | Completers of Week 24 Population Flag |
| DSRAEFL | Discontinued due to AE? |
| **Variable Name** | **Variable Description** |
|---------------------|---------------------------------------|
| STUDYID | Study Identifier |
| USUBJID | Unique Subject Identifier |
| SUBJID | Subject Identifier for the Study |
| SITEID | Study Site Identifier |
| SITEGR1 | Pooled Site Group 1 |
| TRTSDT | Date of First Exposure to Treatment |
| TRTEDT | Date of Last Exposure to Treatment |
| AGE | Age |
| AGEGR1 | Pooled Age Group 1 |
| AGEGR1N | Pooled Age Group 1 (N) |
| RACE | Race |
| RACEN | Race (N) |
| SEX | Sex |
| SAFFL | Safety Population Flag |
| ITTFL | Intent-To-Treat Population Flag |
| EFFFL | Efficacy Population Flag |
| COMP24FL | Completers of Week 24 Population Flag |
| DSRAEFL | Discontinued due to AE? |

## Treatment Variables

Expand All @@ -136,8 +137,8 @@ Use of ADaM Treatment Variables in Analysis
Are both planned and actual treatment variables used in analysis?
Yes. Planned treatment variables are used for study population and efficacy
analyses, whilst actual treatment variables are used for the safety analysis.
All subjects received the treatment arm to which they were randomised and so
analyses, whilst actual treatment variables are used for the safety analysis.
All subjects received the treatment arm to which they were randomised and so
the planned treatment is equivalent to the actual treatment for all subjects.
```

Expand All @@ -154,13 +155,13 @@ Use of ADaM Treatment Grouping Variables in Analysis
Was windowing used in one or more analysis datasets?

```
Yes
Yes
```

Were unscheduled visits used in any analyses?

```
Yes
Yes
```

## Imputation/Derivation Methods
Expand All @@ -177,13 +178,12 @@ There were no datasets that required splitting due to size constraints.

## Data Dependencies

| | |
|----------------------|----------------------------------------------|
| **Analysis Dataset** | **Dependent on Following Analysis Datasets** |
| ADAE | ADSL |
| ADTTE | ADSL, ADAE |
| ADLBC | ADSL |
| ADADAS | ADSL |
| **Analysis Dataset** | **Dependent on Following Analysis Datasets** |
|------------------------|----------------------------------------------|
| ADAE | ADSL |
| ADTTE | ADSL, ADAE |
| ADADAS | ADSL |
| ADLBC | ADSL |

## Intermediate Datasets

Expand Down Expand Up @@ -225,7 +225,7 @@ The following provides detailed information for each analysis dataset included i
| ADTTE - AE Time To 1st Derm. Event Analysis | BASIC DATA STRUCTURE | x | x | | | One or more records per subject per analysis parameter per analysis timepoint |
+----------------------------------------------+--------------------------------+----------+--------+-------------------------+-----------+-------------------------------------------------------------------------------+

: {tbl-colwidths="\[15,15,5,5,15,5,15\]"}
: {tbl-colwidths="\[20,20,10,10,20,10,10\]"}

### ADSL - Subject-Level Analysis Dataset

Expand Down Expand Up @@ -257,7 +257,7 @@ Were the analysis datasets evaluated for conformance with CDISC ADaM Validation

```
Yes, Version of CDISC ADaM Validation Checks and software used: Pinnacle 21®
Community 4.0.2
Community 4.0.2
```

Were the ADaM datasets evaluated in relation to define.xml?
Expand All @@ -279,6 +279,8 @@ Was define.xml evaluated?
+==========+==============================================================================+=========+====================+=========================================================================================================================================================================================+
| AD1012 | Secondary custom variable is present but its primary variable is not present | ADSL | 1 (50.00%) | This is a Sponsor Extension to the ADaM Model. The VISNUMEN \[End of Trt Visit (Vis 12 or Early Term.)\] variable is a integer variable which is not related to any character variable. |
+----------+------------------------------------------------------------------------------+---------+--------------------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+
: {tbl-colwidths="\[17,22,15,22,25\]"}


## QC Findings and Common Issues

Expand Down

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