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These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.
TO provides a mechanism for uniquely identifying a tobacco product and is the source of the SPTOBID variable. For more information on this domain, see Section 3.1.1, Tobacco Product Identifiers and Descriptors. Only 1 tobacco product was of interest in the study. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-121
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These product malfunctions and events are represented in EM. Events not specifically associated with the product device should not be represented in this domain.
The applicant used a standardized or dictionary-derived text for the description of an issue or events. (Note: CDISC does not prescribe what standardized or dictionary-derived text should be used.) The applicant decided to use the This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger. The sponsor did not collect device events for the heatstick used in the System Holder and Charger. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the terminologies for categorized adverse event reporting for the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element . DEDCODE (see Section 2.10, Standards for Data Exchange).
EMDECOD was the Level 3 IMDRF term. NSVs were used to represent the various coding level variables defined in the dictionary.
Example
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SUPPEM Variable Metadata
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Variable
Label
Type
DEDECOD Standardized Meal Name
| Variable |
|---|
| Label |
|---|
| Type | Codelist |
|---|
| EMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
Codelist | External Dictionary Name | Dictionary Version | Reference |
|---|---|---|---|
| IMDRFANNEXA | IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes: Annex A | Release Number: 2022 |
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Describe the device event.
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The SDTM EM dataset is shown below.
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The SUPPEM dataset is used to represent the NSVs used for coding the malfunction or event. The parent domain (RDOMAIN) is EM, and IDVAR is EMSEQ. QNAM holds the name of the supplemental qualifier variable being defined. This only shows the data for subject 2029. The data recorded in QVAL applies to the subject’s records, where IDVAR (EMSEQ) equals the value specified in IDVARVAL.
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The associated SDTM datasets for the data collected above are provided below. The DI domain is used to identify the device. Only one device was of interest in the study.
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In this study, subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below for brevity.
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The RELREC dataset was used to record the relationship between the EM dataset and any reported AE represented in the AE dataset.
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| Variable | Label | Type | Role | Origin | DEIMDRDC | IMDRF Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | DEIMDRFL2 | IMDRF Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | DEIMDRFL1 | IMDRF Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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