| Name | Type | Size | Values | Tooltip message |
|---|---|---|---|---|
| Image | text | 25 | ||
| Title | text | 25 | ||
| Graph_Subgroup | radio | 4 | General Principles, Labs Liver, ECGVitals, Adverse Events | |
| Labs_Liver_Clinical_Question | checkbox | 1 | Baseline: 1. What are the changes and percent changes from baseline over time? ie are abnormal labl values a result of abnormal baseline or have values changed on study?, Baseline: 2. Is there a temporal relationship between treatment and lab value?, Baseline: 3. What are the toxicity grade trends over time?, Baseline: 4. What is the patient's profile over time? ie display values for multiple lab paramets for subject(s) of interest, Association: 1. What is the association between lab assessments? Are multiple lab values that are elevated or abnormal - either concurrently or not? ie how can we easily identify patients with simultaneous elevations in multiple lab tests over time?, LFT: How do we perform a comprehensive assessment of hepato-toxicity so that possible cases of drug induced liver injury are efficiently identified?, LFT: What are the maximum LFT values (or any max lab values) over time during the course of the study?, Gen: Are there graphics which can AID in determining emerging safety signals? |
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| Description | textarea | 80x10 | ||
| Contributor/Email | textarea | 15 | Name and email contact of the author(s) | |
| Additional_Contributor_Info | textarea | 15 | Additional contributors or information | |
| Background | textarea | 80x10 | Reason for the graphic (this could list the clinical question). This field could also describe the motivation for the graphic. | |
| Keywords | text | 80 | listing of any keywords that can be used to identify the graphic (these may be hyperlinked). Some examples are: liver, labs, ECG, vitals, adverse events, MedDRA. | |
| References | textarea | 80x10 | Links or references | |
| Datasets | checkbox | 4 | CDISC Datasets, Vanderbilt Datasets, Other | Mark dataset(s) used. |
| CDISC_Data | checkbox | 4 | ADAE, ADLBC | |
| Data_Format | text | 40 | Attach an example of the data format | |
| CLASSIFICATIONS | label | |||
| Graph_Type | checkbox | 4 | Bar charts, Histogram, Boxplot, Density Plot, Dotplot,Forest Plot, Line Plot, Modeling Plots, Mosaic Plot, Perspective Plot, Pie Chart, Scatterplot, Survival Plot, Volcano Plots, Profile Plot, Other | |
| Variable_Relationship | checkbox | 2 | Categorical versus Categorical, Continuous versus Categorical, Continuous versus Categorical Conditioned, Continuous versus Continuous, Continuous versus Continuous Conditioned, Summary, Survival | |
| Data_Types | checkbox | 1 | Categorical, Continuous, Categorical and Continuous, Time to Event | |
| Special_Considerations | textarea | 80 x 10 | Add any special considerations | |
| Code_Available | radio | 2 | Yes, No | |
| Software Program | checkbox | 4 | R, SAS, Stata, other | |
| Software | textarea | 25 | What software was used to create the graphic (include any relevant version numbers). | |
| R-Code - Attachment | text | 80 | ||
| R-Code | textarea | 80x10 | ||
| SAS-Code - Attachment | text | 80 | Please link and provide name of contributor. | |
| SAS-Code - v9.2 - Attachment | text | 80 | Please link and provide name of contributor. | |
| Stata-Code - Attachment | text | 80 | ||
| Stata-Code | textarea | 80x10 | ||
| Other Code - Attachment | text | 80 | ||
| Other Code | textarea | 80x10 | ||
| Disclaimer | label | 80x10 | The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated. | |
| Permission | label | 80x10 | Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions: The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software. THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF ERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT OLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. |
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| Click here to add comments | label | |||
| Reference Image | text | 25 |