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BioAssay: AID 588216

FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase

The FDA's Spontaneous Reporting System (SRS) database contains over 1.5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects. We have linked the trade names of the drugs to 1861 generic names and retrieved molecular structures for each chemical to obtain a set of 1515 more ..
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 Tested Compounds
 Tested Compounds
All(489)
 
 
Active(84)
 
 
Unspecified(405)
 
 
 Tested Substances
 Tested Substances
All(502)
 
 
Active(86)
 
 
Unspecified(416)
 
 
 Related BioAssays
 Related BioAssays
AID: 588216
Data Source: ChEMBL (736789)
Depositor Category: Literature, Extracted
BioAssay Version:
Deposit Date: 2011-09-18
Modify Date: 2014-05-27

Data Table ( Complete ):           Active    All
BioActive Compounds: 84
Description:
Title: Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.

Abstract: The FDA's Spontaneous Reporting System (SRS) database contains over 1.5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects. We have linked the trade names of the drugs to 1861 generic names and retrieved molecular structures for each chemical to obtain a set of 1515 organic chemicals that are suitable for modeling with commercially available QSAR software packages. ADR report data for 631 of these compounds were extracted and pooled for the first five years that each drug was marketed. Patient exposure was estimated during this period using pharmaceutical shipping units obtained from IMS Health. Significant drug effects were identified using a Reporting Index (RI), where RI = (# ADR reports / # shipping units) x 1,000,000. MCASE/MC4PC software was used to identify the optimal conditions for defining a significant adverse effect finding. Results suggest that a significant effect in our database is characterized by > or = 4 ADR reports and > or = 20,000 shipping units during five years of marketing, and an RI > or = 4.0. Furthermore, for a test chemical to be evaluated as active it must contain a statistically significant molecular structural alert, called a decision alert, in two or more toxicologically related endpoints. We also report the use of a composite module, which pools observations from two or more toxicologically related COSTAR term endpoints to provide signal enhancement for detecting adverse effects.
(PMID: 16472241)
Comment
Putative Target:

ChEMBL Target ID: 103956
Target Type: PHENOTYPE
Pref Name: Hepatotoxicity
Confidence: Target assigned is non-molecular
Relationship Type: Non-molecular target assigned
Categorized Comment
Assay Type: ADME

Assay Data Source: Scientific Literature

Result Definitions
Show more
TIDNameDescriptionHistogramTypeUnit
OutcomeThe BioAssay activity outcomeOutcome
1SGOT Increase - Activity Score activity commentSGOT Increase - Activity Score activity commentString
2SGOT Increase - Activity Score standard flagSGOT Increase - Activity Score standard flagInteger
3SGOT Increase - Activity Score qualifierSGOT Increase - Activity Score qualifierString
4SGOT Increase - Activity Score published valueSGOT Increase - Activity Score published valueFloat
5SGOT Increase - Activity Score standard valueSGOT Increase - Activity Score standard valueFloat
6SGOT Increase - Index Value activity commentSGOT Increase - Index Value activity commentString
7SGOT Increase - Index Value standard flagSGOT Increase - Index Value standard flagInteger
8SGOT Increase - Index Value qualifierSGOT Increase - Index Value qualifierString
9SGOT Increase - Index Value published valueSGOT Increase - Index Value published valueFloat
10SGOT Increase - Index Value standard valueSGOT Increase - Index Value standard valueFloat
11SGOT Increase - Number of Reports activity commentSGOT Increase - Number of Reports activity commentString
12SGOT Increase - Number of Reports standard flagSGOT Increase - Number of Reports standard flagInteger
13SGOT Increase - Number of Reports qualifierSGOT Increase - Number of Reports qualifierString
14SGOT Increase - Number of Reports published valueSGOT Increase - Number of Reports published valueFloat
15SGOT Increase - Number of Reports standard valueSGOT Increase - Number of Reports standard valueFloat

Data Table (Concise)
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