| Name | Type | Size | Values | Tooltip message |
|---|---|---|---|---|
| Title | text | 25 | ||
| Figure No. | text | 25 | ||
| Image | text | 25 | ||
| Graph Displayed | radio | 3 | class, individual | |
| Graph Subgroup | radio | 4 | General Principles, Labs Liver, ECGVitals, Adverse Events | |
| Code Added | radio | 2 | Yes, No | |
| Question Classification | checkbox | 4 | Baseline and Trending over Time, Association between Lab Variables, Liver Function Tests, General Labs Liver | |
| Clinical Questions Answered | checkbox | 1 | Are abnormal lab values a result of a borderline baseline lab value?, What are the changes and percent changes from baseline for subjects whose baseline values were within normal limits?, Is it possible to display the time course of changes in lab value?, What are the toxicity grade trends over time? (What specifically would you be looking for in a trend?), What is the patient\x92s profile over time?, Are there multiple lab values that are abnormal (either concurrently or not)?, How can we easily identify patients with simultaneous elevations in LFTs or lab tests over time?, Once we have identified subjects of interest - what are the specific lab values over time and is it possible to see multiple parameters at once?, Were there concurrent elevations in multiple lab parameters (by study and by subject)?, How do we perform a comprehensive assessment of hepato-toxicity?, How can we efficiently identify possible cases of drug induced liver injury?, What are the maximum LFT values (or any max lab values) over time during the course of the study?, Does there seem to be a relationship between the timing of lab abnormalities and start of treatment?, How many subjects were above the ULN for any given lab parameter during the study?, What is the lab profile of the entire study?, Are there graphics which can aid in determining emerging safety signals?, Does there seem to be a treatment effect for any of the lab values?, How does the treatment affect the subjects biochemistry?, What is the hazard for developing a low lab count over time while on treatment?, Are there specific events that occur simultaneously with abnormal lab values?, Are there effective means of transitioning from whole population level to individual level?, How can we display values for multiple lab parameters for subjects of interest? | |
| Description | textarea | 20 | ||
| Special Considerations | textarea | 80x10 | List any special considerations in using this graphic. | |
| Data Types | checkbox | 1 | Categorical, Continuous, Categorical and Continuous, Time to Event | |
| Contributor/Email | textarea | 15 | Name and email contact of the contributor | |
| Classification-Graph Type | checkbox | 4 | Bar charts, Histogram, Boxplot, Density Plot, Dotplot, Forest Plot, Line Plot, Modeling Plots, Mosaic Plot, Other, Perspective Plot, Pie Chart, Scatterplot, Survival Plot, Volcano Plots | |
| Graphic | checkbox | 2 | Reference Graphic, Created Graphic | |
| Source - Reference Graphic | textarea | 20 | ||
| Source - Created Graphic | textarea | 20 | ||
| Created by | text | 25 | ||
| Datasets | checkbox | 4 | CDISC Datasets, Vanderbilt Datasets, Other | Mark dataset(s) used. |
| Data | textarea | 80x10 | Description of the data used to create the graphic | |
| Attached Data | textarea | 40 x 5 | Attach data | |
| Software Program | radio | 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 | ||
| SAS-Code | textarea | 80x10 | ||
| Stata-Code - Attachment | text | 80 | ||
| Stata-Code | textarea | 80x10 | ||
| Other Code - Attachment | text | 80 | ||
| Other Code | textarea | 80x10 | ||
| Special Cases | textarea | 80x10 | List any special cases of this 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. | |
| 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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| Reference Image | text | 25 |