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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Multiple Adverse Events

0 Shared Subjects

N/A
Clinical Assessments
Adverse Events
08/30/2016
mae01
11/21/2023
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0::1440 Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
ae String 4,000 Recommended Adverse event Description ae1_name
aestdd Date Recommended AE start date MM/DD/YYYY ae1_startdate
aeendd Date Recommended AE end date MM/DD/YYYY ae1_stopdate
aesev Integer Recommended Severity 1 :: 5;-9;999 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; 5=Death; -9=Unknown; 999= Missing ae1_severity
aerel Integer Recommended Relatedness 1 :: 5;999 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related; 4= Possibly Related; 5= Probably Related; 999= Missing ae1_relation_inflix
aeout Integer Recommended Outcome 1 :: 20;-9;999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; 13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving; 16= returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving ; 19 = Worsened; 20= Unresolved; -9=unknown; 999= Missing ae1_outcome
aeacn Integer Recommended Action taken 1 :: 14;99;999 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 6= Drug interrupted; 7= Not applicable; 8= Unknown; 9 = Dose increased; 10 = Delayed; 11=Change Administration Time; 12= No Action; 13= Interrupted; 14= Discontinued; 99=Other; 999= Missing ae1_action
aeser Integer Recommended Serious 0;1; -9 0 = No; 1 = Yes; -9=unknown ae1_serious
aes2 String 500 Recommended Description of Adverse Event2 ae2_name
aes2date Date Recommended Adverse Event2 Onset Date ae2_startdate
ae2_stopdate Date Recommended Adverse Event 2 Stop Date
aes2svrt Integer Recommended Severity of AE 2 1::3 1 = Mild; 2 = Moderate; 3 = Severe ae2_severity
ae2_relation Integer Recommended Adverse Event 2 Relationship to study drug 1::3 1= related; 2= not related; 3= possibly related ae2_relation_inflix
ae2_outcome Integer Recommended Adverse Event 2 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae2_action Integer Recommended Adverse Event 2 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae2_serious Integer Recommended Adverse Event 2 Serious 0;1 0=no; 1=yes
aes3 String 500 Recommended Description of Adverse Event3 ae3_name
aes3date Date Recommended Adverse Event3 Onset Date ae3_startdate
ae3_stopdate Date Recommended Adverse Event 3 Stop Date
aes3svrt Integer Recommended Severity of AE 3 0::3 1 = Mild; 2 = Moderate; 3 = Severe; 0=Absent ae3_severity
ae3_relation Integer Recommended Adverse Event 3 Relationship to study drug 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae3_relation_inflix
ae3_outcome Integer Recommended Adverse Event 3 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae3_action Integer Recommended Adverse Event 3 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae3_serious Integer Recommended Adverse Event 3 Serious 0;1 0=no; 1=yes
aesa21d String 500 Recommended Description of Adverse Event4 ae4_name
ae4_startdate Date Recommended Adverse Event 4 Start Date
ae4_stopdate Date Recommended Adverse Event 4 Stop Date
ae4_severity Integer Recommended Adverse Event 4 Severity 1::3 1= mild; 2= moderate; 3= severe
ae4_relation Integer Recommended Adverse Event 4 Relationship to study drug 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae4_relation_inflix
ae4_outcome Integer Recommended Adverse Event 4 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae4_action Integer Recommended Adverse Event 4 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae4_serious Integer Recommended Adverse Event 4 Serious 0;1 0=no; 1=yes
ae5_name String 500 Recommended Adverse Event 5 Name
ae5_startdate Date Recommended Adverse Event 5 Start Date
ae5_stopdate Date Recommended Adverse Event 5 Stop Date
ae5_severity Integer Recommended Adverse Event 5 Severity 1::3 1= mild; 2= moderate; 3= severe
ae5_relation Integer Recommended Adverse Event 5 Relationship to study drug 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae5_relation_inflix
ae5_outcome Integer Recommended Adverse Event 5 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae5_action Integer Recommended Adverse Event 5 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae5_serious Integer Recommended Adverse Event 5 Serious 0;1 0=no; 1=yes
ae6_name String 500 Recommended Adverse Event 6 Name
ae6_startdate Date Recommended Adverse Event 6 Start Date
ae6_stopdate Date Recommended Adverse Event 6 Stop Date
ae6_severity Integer Recommended Adverse Event 6 Severity 1::3 1= mild; 2= moderate; 3= severe
ae6_relation Integer Recommended Adverse Event 6 Relationship to study drug 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae6_relation_inflix
ae6_outcome Integer Recommended Adverse Event 6 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae6_action Integer Recommended Adverse Event 6 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae6_serious Integer Recommended Adverse Event 6 Serious 0;1 0=no; 1=yes
ae7_name String 500 Recommended Adverse Event 7 Name
ae7_startdate Date Recommended Adverse Event 7 Start Date
ae7_stopdate Date Recommended Adverse Event 7 Stop Date
ae7_severity Integer Recommended Adverse Event 7 Severity 1::3 1= mild; 2= moderate; 3= severe
ae7_relation Integer Recommended Adverse Event 7 Relationship to study drug 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related ae7_relation_inflix
ae7_outcome Integer Recommended Adverse Event 7 Outcome 1::19; -9 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae7_action Integer Recommended Adverse Event 7 Action Taken 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown; 9 = Dose increased; 10 = Delayed; 11 = Change Administration Time
ae7_serious Integer Recommended Adverse Event 7 Serious 0;1 0=no; 1=yes
ae10_outcome Integer Recommended Adverse Event 10 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae10_action Integer Recommended Adverse Event 10 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae10_serious Integer Recommended Adverse Event 10 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae11_name String 500 Recommended Adverse Event 11 Name
ae11_startdate Date Recommended Adverse Event 11 Start Date
ae11_stopdate Date Recommended Adverse Event 11 Stop Date
ae11_severity Integer Recommended Adverse Event 11 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae11_relationship Integer Recommended Adverse Event 11 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related
ae11_outcome Integer Recommended Adverse Event 11 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae11_action Integer Recommended Adverse Event 11 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae11_serious Integer Recommended Adverse Event 11 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae12_name String 500 Recommended Adverse Event 12 Name
ae12_startdate Date Recommended Adverse Event 12 Start Date
ae12_stopdate Date Recommended Adverse Event 12 Stop Date
ae12_severity Integer Recommended Adverse Event 12 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae12_relationship Integer Recommended Adverse Event 12 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related
ae12_outcome Integer Recommended Adverse Event 12 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae12_action Integer Recommended Adverse Event 12 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae12_serious Integer Recommended Adverse Event 12 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae13_name String 500 Recommended Adverse Event 13 Name
ae13_startdate Date Recommended Adverse Event 13 Start Date
ae13_stopdate Date Recommended Adverse Event 13 Stop Date
ae13_severity Integer Recommended Adverse Event 13 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae13_relationship Integer Recommended Adverse Event 13 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related
ae13_outcome Integer Recommended Adverse Event 13 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae13_action Integer Recommended Adverse Event 13 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae13_serious Integer Recommended Adverse Event 13 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae14_name String 500 Recommended Adverse Event 14 Name
ae14_startdate Date Recommended Adverse Event 14 Start Date
ae14_stopdate Date Recommended Adverse Event 14 Stop Date
ae14_severity Integer Recommended Adverse Event 14 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae14_relationship Integer Recommended Adverse Event 14 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related
ae14_outcome Integer Recommended Adverse Event 14 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae14_action Integer Recommended Adverse Event 14 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae14_serious Integer Recommended Adverse Event 14 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
version_form String 121 Recommended Form used/assessment name
ae8_name String 500 Recommended Adverse Event 8 Name
ae8_startdate Date Recommended Adverse Event 8 Start Date
ae8_stopdate Date Recommended Adverse Event 8 Stop Date
ae8_severity Integer Recommended Adverse Event 8 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae8_relation Integer Recommended Adverse Event 8 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related ae8_relation_inflix
ae8_outcome Integer Recommended Adverse Event 8 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae8_action Integer Recommended Adverse Event 8 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae8_serious Integer Recommended Adverse Event 8 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae9_name String 500 Recommended Adverse Event 9 Name
ae9_startdate Date Recommended Adverse Event 9 Start Date
ae9_stopdate Date Recommended Adverse Event 9 Stop Date
ae9_severity Integer Recommended Adverse Event 9 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae9_relation Integer Recommended Adverse Event 9 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related ae9_relation_inflix
ae9_outcome Integer Recommended Adverse Event 9 Outcome 1::19; -9; 999 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15 = recovered/resolving; 16 = returned to baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving; 19 = Worsened
ae9_action Integer Recommended Adverse Event 9 Action Taken
1 :: 4
1 = drug interrupted; 2 = drug withdrawn; 3 = not applicable; 4 = unknown
ae9_serious Integer Recommended Adverse Event 9 Serious (yes/no) 0 :: 1 0 = no; 1 = yes
ae10_name String 500 Recommended Adverse Event 10 Name
ae10_startdate Date Recommended Adverse Event 10 Start Date
ae10_stopdate Date Recommended Adverse Event 10 Stop Date
ae10_severity Integer Recommended Adverse Event 10 Severity 1 :: 3 1 = mild; 2 = moderate; 3 = severe
ae10_relation Integer Recommended Adverse Event 10 Relationship to study drug 1 :: 3 1 = not related; 2 = possibly/probably related; 3 = definitely related ae10_relation_inflix
ae14_action_alt Integer Recommended Adverse Event 14 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae2_relation_alt Integer Recommended Adverse Event 2 Relationship to study drug (Alternative Coding) 1::3 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related
ae8_action_alt Integer Recommended Adverse Event 8 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae9_action_alt Integer Recommended Adverse Event 9 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae10_action_alt Integer Recommended Adverse Event 10 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae11_action_alt Integer Recommended Adverse Event 11 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae12_action_alt Integer Recommended Adverse Event 12 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
ae13_action_alt Integer Recommended Adverse Event 13 Outcome (Alternative Coding) 1::11;99 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Time
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

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