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Topic revision: 24 Feb 2012, MaryBanach
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| Image | %LIGHTBOX{ image="vitals_postural_changes_by_time.jpg" thumbnail="vitals_postural_Reference_200.jpg" caption="Blood Pressure Postural Changes" }% Click on image to enlarge. |
| Title | Vital Signs: Postural Change by Time and Treatment |
| Description | Often in early clinical trials blood pressure data is collected in supine and standing positions. The difference (Standing - Supine) is expected to be positive but if BP drops from the supine to standing position it could result in fainting. Plots of this Postural Change by Time are often used to evaluate the potential of a drug for untoward AEs such as fainting and syncope. |
| Contributor/Email | Rich Anziano (Richard.J.Anziano@Pfizer.com) |
| Background | |
| Special Considerations | |
| Original Date | |
| Modified Date | |
| Use/Suitability | Exploration, Presentation |
| Software Program | |
| Software | PPD Patient Profiles (CrossGraphs) |
| R-Code - Attachment | |
| R-Code | |
| SAS-Code - Attachment | |
| SAS-Code | |
| Stata-Code - Attachment | |
| Stata-Code | |
| Other Code - Attachment | |
| Other Code | |
| Keywords | |
| OPTIONAL FIELDS | |
| References | |
| Datasets | |
| Data | This vital signs data was simulated from a typical dose escallation FIH trial. Vital Signs data (Systolic/Diastolic BP, and Pulse) were measured at screening, pre-dose, and at 1, 2, 4, 6, 12, 24 and 48 hours following a single dose. Collections were made in the supine and standing positions. BMI, Height, and Weight were also collected at screening. There are 56 subjects in the dataset. If there were no missing data there would have been 56 subjects x 7 timepoints x 2 positions per timepoint x 3 vs collections (systolic, diastolic, bp) = 2352 observations in the post screening phase. For BMI, Height and Weight which was only collected at screening, there would be 56 observations corresponding to one obs per subject. Dataset Links: SAS Transport Dataset: Included as attachment - vitals.dst Comma Delimited ASCII: Included as attachment - vitals.dat * Click on hyperlink for Comma Delimited ASCII File |
| Attached Data | |
| CATEGORIZATIONS | |
| Classification-Evaluation | Safety |
| Classification-Graph Type | |
| Variable Relationship | Continuous versus Continuous |
| Data Types | Continuous |
| Special Cases | |
| Disclaimer | 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 | 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. |
| Reference Image |  |
Topic revision: 24 Feb 2012, MaryBanach
Copyright © by the contributing authors. All material on this collaboration platform is the property of the contributing authors. Ideas, requests, problems regarding Foswiki? Send feedback