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 |
VALUE_RANGE, |
VALUE_RANGE: 1::8; 99 |
VALUE_RANGE: 1::11;99 |
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_outcome |
VALUE_RANGE, |
VALUE_RANGE: 1::15 |
VALUE_RANGE: 1::19; -9 |
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_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_outcome |
VALUE_RANGE, |
VALUE_RANGE: 1::15 |
VALUE_RANGE: 1::19; -9 |
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
|
ae4_action |
VALUE_RANGE, |
VALUE_RANGE: 1::8; 99 |
VALUE_RANGE: 1::11;99 |
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_outcome |
VALUE_RANGE, |
VALUE_RANGE: 1::15 |
VALUE_RANGE: 1::19; -9 |
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
|
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 |
VALUE_RANGE, |
VALUE_RANGE: 1::3 |
VALUE_RANGE: 1 :: 5;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
|
aesev |
VALUE_RANGE, |
VALUE_RANGE: 1::5; -9 |
VALUE_RANGE: 1 :: 5;-9;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
|
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 |
VALUE_RANGE, |
VALUE_RANGE: 1::18; -9 |
VALUE_RANGE: 1::19; -9 |
09/29/2020 12:23 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 |
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
|
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
|