|
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 = 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 = 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 = 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 = 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 = 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 = 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 = 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
|
|