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ADAE ppt-1

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116 views17 pages

ADAE ppt-1

Uploaded by

divyamudiraj2396
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ADAE

Analysis Data Model


(ADaM) Data Structure for
Adverse Event Analysis

SRINIVAS
MADDUKURI
introduction
 Occurrence analysis is the counting of subjects with a given record or term, and often
includes a structured hierarchy of dictionary coding categories.
INTRODUCTION:
 Any untoward medical occurrence in a
patient or clinical investigation subject
administered a pharmaceutical product
and which does not necessarily have to
have a causal relationship with this
treatment
 The safety evaluation of a clinical trial
includes the analysis of adverse events
Adverse Event Attributes
 level of severity of the AE (Mild, Moderate, or
Severe)
 whether the AE is considered to be related to the
study product (Yes or No)
 and whether the AE is considered serious (Yes or
No)
 treatment emergent Is an event that emerges
during treatment having been absent pre-treatment,
or worsens relative to the pre-treatment stat
 Other attributes of AEs include the action taken in
response to the event and whether the event led to
permanent discontinuation of the investigational
product.
Coding of Adverse
Events
 Adverse events are recorded in textual or ‘verbatim’
terms
 Verbatim terms are then processed through a coding

dictionary so that similar verbatim terms are grouped


together by classifying each verbatim term into a
hierarchy of medical granularity
 CODING DICTONARIES:

1. MedRA(Medical Dictionary for Regulatory Activities)


2. WHO-ART(WHO Adverse Reaction Terminology)
3. COSTART( Coding Symbols for a Thesaurus of Adverse
Reaction Terms)
4. ICD(International Classification of Disease )
levels of terms in the MedDRA
hierarchy

System Organ Class (SOC)


High Level Group Term (HLGT)
High Level Term (HLT)
Lowest Level Term (LLT)
Preferred Term (PT)
ADAE
(Adverse Event Analysis
Dataset )
one record per subject per each AE
recorded in SDTM AE domain
ADAE variables
Dictionary Coding
Variables
Timing Variables
INDICATOR VARIABLES
Occurrence Flag
Variables
Treatment Variables
Descriptive Variables

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