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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL
Change History For

Multiple Adverse Events

0 Shared Subjects

N/A
Clinical Assessments
Adverse Events
08/30/2016
mae01
11/21/2023
View Data Structure
01
Definition
Submission Template
Element Name Change Description Before Now When
interview_age VALUE_RANGE, VALUE_RANGE: 0 :: 1260 VALUE_RANGE: 0::1440 04/04/2024 13:54 PM
ae10_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae11_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae12_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae13_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae14_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae2_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae2_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae2_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae3_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae3_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae3_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae3_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae4_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae4_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae4_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae4_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae5_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae5_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae5_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae6_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae6_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae7_action NOTES, NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown NOTES: 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 11/21/2023 09:41 AM
ae7_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae8_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae9_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae10_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae11_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae12_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae13_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae14_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae2_outcome NOTES, NOTES: 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 NOTES: 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 11/21/2023 09:41 AM
ae5_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae6_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae6_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae7_action VALUE_RANGE, VALUE_RANGE: 1::8; 99 VALUE_RANGE: 1::11;99 11/21/2023 09:41 AM
ae7_outcome VALUE_RANGE, VALUE_RANGE: 1::15 VALUE_RANGE: 1::19; -9 11/21/2023 09:41 AM
ae8_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae9_outcome VALUE_RANGE, VALUE_RANGE: 1::15; 999 VALUE_RANGE: 1::19; -9; 999 11/21/2023 09:41 AM
ae10_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae10_action_alt NEW_MAP_ELEMENT Added data element 'ae10_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae11_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae11_action_alt NEW_MAP_ELEMENT Added data element 'ae11_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae12_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae12_action_alt NEW_MAP_ELEMENT Added data element 'ae12_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae13_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae13_action_alt NEW_MAP_ELEMENT Added data element 'ae13_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae14_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae14_action_alt NEW_MAP_ELEMENT Added data element 'ae14_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae2_relation_alt NEW_MAP_ELEMENT Added data element 'ae2_relation_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae8_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae8_action_alt NEW_MAP_ELEMENT Added data element 'ae8_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae9_action_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
ae9_action_alt NEW_MAP_ELEMENT Added data element 'ae9_action_alt' to data structure 'mae01'. 11/21/2023 09:41 AM
ae2_relation_alt NEW_DATA_ELEMENT 11/21/2023 09:41 AM
aeacn NOTES, NOTES: 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 NOTES: 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 08/25/2023 13:18 PM
aeout NOTES, NOTES: 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 NOTES: 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 08/25/2023 13:18 PM
aeacn VALUE_RANGE, VALUE_RANGE: 1::11;99 VALUE_RANGE: 1 :: 14;99;999 08/25/2023 13:18 PM
aeout VALUE_RANGE, VALUE_RANGE: 1::19; -9 VALUE_RANGE: 1 :: 20;-9;999 08/25/2023 13:18 PM
aerel NOTES, NOTES: 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related NOTES: 1 = Not related; 2 = Possibly/Probably related; 3 = Definitely related; 4= Possibly Related; 5= Probably Related; 999= Missing 08/25/2023 13:18 PM
aerel VALUE_RANGE, VALUE_RANGE: 1::3 VALUE_RANGE: 1 :: 5;999 08/25/2023 13:18 PM
aesev NOTES, NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; 5=Death; -9=unknown NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; 5=Death; -9=Unknown; 999= Missing 08/25/2023 13:18 PM
aesev VALUE_RANGE, VALUE_RANGE: 1::5; -9 VALUE_RANGE: 1 :: 5;-9;999 08/25/2023 13:18 PM
ae ELEMENT_SIZE, ELEMENT_SIZE: 500 ELEMENT_SIZE: 4000 04/17/2023 14:18 PM
ae7_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae2_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae3_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae4_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae5_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae5_name ELEMENT_SIZE, ELEMENT_SIZE: 20 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
ae6_action VALUE_RANGE, VALUE_RANGE: 1::8 VALUE_RANGE: 1::8; 99 02/09/2023 14:59 PM
ae6_name ELEMENT_SIZE, ELEMENT_SIZE: 20 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
aes3 ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
aesa21d ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
aes2 ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
ae ELEMENT_SIZE, ELEMENT_SIZE: 250 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
ae14_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:59 PM
ae12_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae13_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae10_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae11_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae8_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae9_name ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
ae7_name ELEMENT_SIZE, ELEMENT_SIZE: 20 ELEMENT_SIZE: 500 02/09/2023 14:58 PM
aesev VALUE_RANGE, VALUE_RANGE: 1::4; -9 VALUE_RANGE: 1::5; -9 09/06/2022 12:01 PM
aesev NOTES, NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknown NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; 5=Death; -9=unknown 09/06/2022 12:01 PM
sex DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of subject at birth 07/09/2021 10:38 AM
interview_date NOTES, NOTES: Required field NOTES: 01/08/2021 10:21 AM
aeout NOTES, NOTES: 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 NOTES: 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 09/29/2020 12:23 PM
aeout VALUE_RANGE, VALUE_RANGE: 1::18; -9 VALUE_RANGE: 1::19; -9 09/29/2020 12:23 PM
version_form ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 121 03/25/2020 12:57 PM
sex VALUE_RANGE, , NOTES, VALUE_RANGE: M;F NOTES: M = Male; F = Female VALUE_RANGE: M;F; O; NR NOTES: M = Male; F = Female; O=Other; NR = Not reported 02/21/2020 13:02 PM
gender PERMANENTLY ALIASED gender sex 04/22/2019 00:00 AM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of the subject 08/22/2018 10:43 AM
gender DESCRIPTION DESCRIPTION: Block Brief 2000: Sex of the subject DESCRIPTION: Sex of the subject 08/20/2018 10:21 AM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Block Brief 2000: Sex of the subject 08/14/2018 16:18 PM
aeout VALUE_RANGE, , NOTES, VALUE_RANGE: 1::17; -9 NOTES: 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 VALUE_RANGE: 1::18; -9 NOTES: 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 05/02/2018 17:32 PM
ae14_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae14_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae12_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae12_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae13_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae13_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae13_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae14_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae10_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae10_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae11_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae11_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae11_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae12_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae10_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae8_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae8_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae9_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae9_action NEW_TRANSLATION_RULE 8 = 4 04/16/2018 19:15 PM
ae9_action NEW_TRANSLATION_RULE 7 = 3 04/16/2018 19:15 PM
ae8_action NEW_TRANSLATION_RULE 6 = 1 04/16/2018 19:15 PM
ae10_name NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae10_name NEW_MAP_ELEMENT Added data element 'ae10_name' to data structure 'mae01'. 04/16/2018 19:12 PM
ae10_relation NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae10_relation NEW_MAP_ELEMENT Added data element 'ae10_relation' to data structure 'mae01'. 04/16/2018 19:12 PM
ae10_severity NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae10_severity NEW_MAP_ELEMENT Added data element 'ae10_severity' to data structure 'mae01'. 04/16/2018 19:12 PM
ae10_startdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae10_startdate NEW_MAP_ELEMENT Added data element 'ae10_startdate' to data structure 'mae01'. 04/16/2018 19:12 PM
ae10_stopdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae10_stopdate NEW_MAP_ELEMENT Added data element 'ae10_stopdate' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_action NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_action NEW_MAP_ELEMENT Added data element 'ae8_action' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_name NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_name NEW_MAP_ELEMENT Added data element 'ae8_name' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_outcome NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_outcome NEW_MAP_ELEMENT Added data element 'ae8_outcome' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_relation NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_relation NEW_MAP_ELEMENT Added data element 'ae8_relation' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_serious NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_serious NEW_MAP_ELEMENT Added data element 'ae8_serious' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_severity NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_severity NEW_MAP_ELEMENT Added data element 'ae8_severity' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_startdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_startdate NEW_MAP_ELEMENT Added data element 'ae8_startdate' to data structure 'mae01'. 04/16/2018 19:12 PM
ae8_stopdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae8_stopdate NEW_MAP_ELEMENT Added data element 'ae8_stopdate' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_action NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_action NEW_MAP_ELEMENT Added data element 'ae9_action' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_name NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_name NEW_MAP_ELEMENT Added data element 'ae9_name' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_outcome NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_outcome NEW_MAP_ELEMENT Added data element 'ae9_outcome' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_relation NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_relation NEW_MAP_ELEMENT Added data element 'ae9_relation' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_serious NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_serious NEW_MAP_ELEMENT Added data element 'ae9_serious' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_severity NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_severity NEW_MAP_ELEMENT Added data element 'ae9_severity' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_startdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_startdate NEW_MAP_ELEMENT Added data element 'ae9_startdate' to data structure 'mae01'. 04/16/2018 19:12 PM
ae9_stopdate NEW_DATA_ELEMENT 04/16/2018 19:12 PM
ae9_stopdate NEW_MAP_ELEMENT Added data element 'ae9_stopdate' to data structure 'mae01'. 04/16/2018 19:12 PM
version_form NEW_MAP_ELEMENT Added data element 'version_form' to data structure 'mae01'. 04/16/2018 18:28 PM
ae10_action NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae10_action NEW_MAP_ELEMENT Added data element 'ae10_action' to data structure 'mae01'. 04/16/2018 18:26 PM
ae10_outcome NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae10_outcome NEW_MAP_ELEMENT Added data element 'ae10_outcome' to data structure 'mae01'. 04/16/2018 18:26 PM
ae10_serious NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae10_serious NEW_MAP_ELEMENT Added data element 'ae10_serious' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_action NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_action NEW_MAP_ELEMENT Added data element 'ae11_action' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_name NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_name NEW_MAP_ELEMENT Added data element 'ae11_name' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_outcome NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_outcome NEW_MAP_ELEMENT Added data element 'ae11_outcome' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_relationship NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_relationship NEW_MAP_ELEMENT Added data element 'ae11_relationship' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_serious NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_serious NEW_MAP_ELEMENT Added data element 'ae11_serious' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_severity NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_severity NEW_MAP_ELEMENT Added data element 'ae11_severity' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_startdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_startdate NEW_MAP_ELEMENT Added data element 'ae11_startdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae11_stopdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae11_stopdate NEW_MAP_ELEMENT Added data element 'ae11_stopdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_action NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_action NEW_MAP_ELEMENT Added data element 'ae12_action' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_name NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_name NEW_MAP_ELEMENT Added data element 'ae12_name' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_outcome NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_outcome NEW_MAP_ELEMENT Added data element 'ae12_outcome' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_relationship NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_relationship NEW_MAP_ELEMENT Added data element 'ae12_relationship' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_serious NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_serious NEW_MAP_ELEMENT Added data element 'ae12_serious' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_severity NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_severity NEW_MAP_ELEMENT Added data element 'ae12_severity' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_startdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_startdate NEW_MAP_ELEMENT Added data element 'ae12_startdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae12_stopdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae12_stopdate NEW_MAP_ELEMENT Added data element 'ae12_stopdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_action NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_action NEW_MAP_ELEMENT Added data element 'ae13_action' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_name NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_name NEW_MAP_ELEMENT Added data element 'ae13_name' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_outcome NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_outcome NEW_MAP_ELEMENT Added data element 'ae13_outcome' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_relationship NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_relationship NEW_MAP_ELEMENT Added data element 'ae13_relationship' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_serious NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_serious NEW_MAP_ELEMENT Added data element 'ae13_serious' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_severity NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_severity NEW_MAP_ELEMENT Added data element 'ae13_severity' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_startdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_startdate NEW_MAP_ELEMENT Added data element 'ae13_startdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae13_stopdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae13_stopdate NEW_MAP_ELEMENT Added data element 'ae13_stopdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_action NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_action NEW_MAP_ELEMENT Added data element 'ae14_action' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_name NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_name NEW_MAP_ELEMENT Added data element 'ae14_name' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_outcome NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_outcome NEW_MAP_ELEMENT Added data element 'ae14_outcome' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_relationship NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_relationship NEW_MAP_ELEMENT Added data element 'ae14_relationship' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_serious NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_serious NEW_MAP_ELEMENT Added data element 'ae14_serious' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_severity NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_severity NEW_MAP_ELEMENT Added data element 'ae14_severity' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_startdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_startdate NEW_MAP_ELEMENT Added data element 'ae14_startdate' to data structure 'mae01'. 04/16/2018 18:26 PM
ae14_stopdate NEW_DATA_ELEMENT 04/16/2018 18:26 PM
ae14_stopdate NEW_MAP_ELEMENT Added data element 'ae14_stopdate' to data structure 'mae01'. 04/16/2018 18:26 PM
version_form DESCRIPTION DESCRIPTION: Form used DESCRIPTION: Form used/assessment name 11/24/2017 16:39 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY DESCRIPTION: Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY 08/28/2017 15:10 PM
version_form NOTES NOTES: 0 NOTES: 08/01/2017 15:06 PM
version_form NOTES NOTES: NOTES: 0 08/01/2017 14:25 PM
ae ELEMENT_SIZE ELEMENT_SIZE: 100 ELEMENT_SIZE: 250 02/10/2017 15:37 PM
aeout VALUE_RANGE VALUE_RANGE: 1::16; -9 VALUE_RANGE: 1::17; -9 02/02/2017 16:38 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::10;99 NOTES: 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 VALUE_RANGE: 1::11;99 NOTES: 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 02/02/2017 16:38 PM
version_form ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 02/02/2017 16:38 PM
aeacn VALUE_RANGE VALUE_RANGE: 1::10; 99 VALUE_RANGE: 1::10;99 12/28/2016 17:59 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::8; 99 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown VALUE_RANGE: 1::10; 99 NOTES: 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 12/05/2016 17:59 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::15; -9 NOTES: 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 VALUE_RANGE: 1::16; -9 NOTES: 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 12/05/2016 17:59 PM
Data Structure Change History

This page displays a list of all the changes that have been made to this data structure since its original definition. You can view the element name, the attribute that was changed, previous and subsequent values, and the timestamp of the change. Use the search bar to filter the displayed changes.

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