ID

43809

Description

The primary goal of the Sentinel pilot is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data. This data model is freely available to all. For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org Description: The SCDM Incident Generic Drug Name Summary Table1 provides a count of unique members with an incident dispensing for each generic drug name of interest stratified by age group, sex, and year. Incidence is defined as a member with a dispensing with the generic drug name of interest (i.e., the index date), in the year of interest with no evidence of a dispensing for that generic drug name in the 90, 180 and 270 days (i.e., the lookback periods) before the index date. Both medical and drug coverage are required during the three possible lookback periods, allowing for eligibility gaps of <=45 days. In addition to reporting the number of members with an incident dispensing, for each such incident user a treatment episode starting on the index date is created, and the total number of dispensings with the generic drug name, days supplied and length of treatment episodes (in days) in the 90, 180, 270 days after the index date are reported. Treatment gaps of <= 15 days are allowed when building treatment episodes and no restriction on the length of treatment episodes is applied. Although a member can have multiple index events in a given calendar year the first one only is counted and used for reporting. This table also reports a count of members with index dates in each quarter which sum up to total number of members for that year.

Link

www.sentinelsystem.org

Keywords

Versions (3)
  1. 2/2/17 2/2/17 -
  2. 2/2/17 2/2/17 -
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model Incident Generic Drug Name

English

Sentinel Common Data Model Incident Generic Drug Name

1 forms  
Incident Generic Drug Name
Description

Incident Generic Drug Name

Alias
UMLS CUI-1
C3699427
UMLS CUI-2
C1551358
Age Group
Description

Age is defined as age at initial cohort eligibility during the period (e.g., age as of the start of coverage).

Data type

text

Alias
UMLS CUI [1]
C0001779
Sex
Description

Any individual not designated as male or female is categorized as unknown.

Data type

text

Year of dispensing
Description

4 digit year

Data type

integer

Alias
UMLS CUI [1]
C0456586
Generic drug name.
Description

Generic drug name. Note: The generic drug name is standardized using a look-up table provided by the SOC.

Data type

text

Alias
UMLS CUI [1]
C3699427
Age Group Id
Description

The unique ID for the Age_Group from the Age Groups Table.

Data type

text

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1300638
Generic Drug Name - Details
Description

Generic Drug Name - Details

Alias
UMLS CUI-1
C3699427
UMLS CUI-2
C1522508
Members during 90/ 180/270 days before the index date.
Description

Count of members who had a dispensing with the generic name during the period with no evidence of another dispensing with that generic name in the 90/ 180/ 270 days before the index date. Only the first incident event/index date within each year is considered.

Data type

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
Dispensings during 90/ 180/ 270 days before the index date.
Description

For members who satisfy the Members90/180/270 criteria, count of dispensings with the generic name 90/ 180/ 270 days after the index date (including the index event).

Data type

integer

Alias
UMLS CUI [1]
C1880359
Days supply during 90/ 180/ 270 days before the index date.
Description

For members who satisfy the Members90/ 180/ 270 criteria, count of days supply on the dispensings with the generic name 90/ 180/ 270 days after the index date (including the index event).

Data type

integer

Alias
UMLS CUI [1,1]
C0243163
UMLS CUI [1,2]
C1948053
Length of Treatment during 90/ 180/ 270 days before the index date.
Description

For members who satisfy the Members90/ 180/ 270 criteria, length of treatment episodes (in days) of the dispensings with the generic name 90/ 180/ 270 days after the index date (including the index event). Treatment gaps of <= 15 days are allowed when building treatment episodes and no restriction on the length of treatment episodes is applied.

Data type

integer

Alias
UMLS CUI [1]
C0444921
Members during 90/ 180/ 270 days before the index date with an index date in Q1.
Description

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q1 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Data type

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205435
Members during 90/ 180/ 270 days before the index date with an index date in Q2.
Description

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q2 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Data type

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205436
Members during 90/ 180/ 270 days before the index date with an index date in Q3.
Description

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q3 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Data type

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205437
Members during 90/ 180/ 270 days before the index date with an index date in Q4.
Description

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q4 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Data type

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205438
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Similar models

Sentinel Common Data Model Incident Generic Drug Name

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Incident Generic Drug Name
C3699427 (UMLS CUI-1)
C1551358 (UMLS CUI-2)
Item
Age Group
text
C0001779 (UMLS CUI [1])
Age
Code List
Age Group
CL Item
0-1 (0-1)
CL Item
2-4 (2-4)
CL Item
5-9 (5-9)
CL Item
10-14 (10-14)
CL Item
15-18 (15-18)
CL Item
19-21 (19-21)
CL Item
22-44 (22-44)
CL Item
45-64 (45-64)
CL Item
65-74 (65-74)
CL Item
75+ (75+)
Item
Sex
text
Gender
Code List
Sex
CL Item
Female (F )
CL Item
Male (M )
CL Item
Unknown (U )
Calendar Year
Item
Year of dispensing
integer
C0456586 (UMLS CUI [1])
Generic Drug Name
Item
Generic drug name.
text
C3699427 (UMLS CUI [1])
Age ID
Item
Age Group Id
text
C0001779 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Generic Drug Name - Details
C3699427 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Count of Members
Item
Members during 90/ 180/270 days before the index date.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Dispensings
Item
Dispensings during 90/ 180/ 270 days before the index date.
integer
C1880359 (UMLS CUI [1])
Days supply
Item
Days supply during 90/ 180/ 270 days before the index date.
integer
C0243163 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Length of Treatment
Item
Length of Treatment during 90/ 180/ 270 days before the index date.
integer
C0444921 (UMLS CUI [1])
Count of Members: Q1
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q1.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
Count of Members: Q2
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q2.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Count of Members: Q3
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q3.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205437 (UMLS CUI [2,2])
Count of Members: Q4
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q4.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205438 (UMLS CUI [2,2])
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