interview_age |
VALUE_RANGE, |
VALUE_RANGE: 0 :: 1260 |
VALUE_RANGE: 0::1440 |
04/04/2024 13:54 PM
|
adev_ch_lastapp |
NEW_DATA_ELEMENT |
|
|
02/14/2024 12:35 PM
|
adev_ch_lastapp |
NEW_MAP_ELEMENT |
|
Added data element 'adev_ch_lastapp' to data structure 'adev01'. |
02/14/2024 12:35 PM
|
adev_ch_lastapp_ex |
NEW_DATA_ELEMENT |
|
|
02/14/2024 12:35 PM
|
adev_ch_lastapp_ex |
NEW_MAP_ELEMENT |
|
Added data element 'adev_ch_lastapp_ex' to data structure 'adev01'. |
02/14/2024 12:35 PM
|
ae_action_1 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_1' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_2' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_3' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_5' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_6' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_7' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_8' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_9' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_1 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_1' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_2' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_3' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_4' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_5' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_6' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_7' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_8' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_comments_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_comments_9' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_1_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_1_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_2_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_2_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_3_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_3_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_4_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_4_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_5_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_5_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_6_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_6_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_7_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_7_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_8_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_8_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_outcome_9_a |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_9_a' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_1 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_2 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_3 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_4 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_4' to data structure 'adev01'. |
12/04/2023 15:41 PM
|
ae_action_5 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_6 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_7 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_8 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_action_9 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_1 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_2 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_3 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_4 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_5 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_6 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_7 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_8 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_comments_9 |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_1_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_2_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_3_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_4_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_5_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_6_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_7_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_8_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
ae_outcome_9_a |
NEW_DATA_ELEMENT |
|
|
12/04/2023 15:41 PM
|
aae03a |
NEW_MAP_ELEMENT |
|
Added data element 'aae03a' to data structure 'adev01'. |
09/21/2023 09:55 AM
|
aae03a |
NEW_DATA_ELEMENT |
|
|
09/21/2023 09:54 AM
|
event1_ongoing |
NEW_MAP_ELEMENT |
|
Added data element 'event1_ongoing' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
event2_ongoing |
NEW_MAP_ELEMENT |
|
Added data element 'event2_ongoing' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
event3_ongoing |
NEW_MAP_ELEMENT |
|
Added data element 'event3_ongoing' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
saa1 |
NEW_MAP_ELEMENT |
|
Added data element 'saa1' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
saa2 |
NEW_MAP_ELEMENT |
|
Added data element 'saa2' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
saa3 |
NEW_MAP_ELEMENT |
|
Added data element 'saa3' to data structure 'adev01'. |
09/05/2023 12:35 PM
|
event1_ongoing |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
event2_ongoing |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
event3_ongoing |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
saa1 |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
saa2 |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
saa3 |
NEW_DATA_ELEMENT |
|
|
09/05/2023 12:34 PM
|
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
|
aef008 |
NOTES, |
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); 7= Physiotherapy; 8= Hospitalization and medicine; 9= Physiotherapy and medicine; 10= Hospitalization and physio; 11= Hospitalization, medicine, and physio; -9=unknown |
NOTES: 1= None; 2= Stop treatment; 3= Medication; 4= Health care; 5= Hospitalization; 6= Other (specify); 7= Physiotherapy; 8= Hospitalization and medicine; 9= Physiotherapy and medicine; 10= Hospitalization and physio; 11= Hospitalization, medicine, and physio; -9=Unknown; 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
|
aef008 |
VALUE_RANGE, |
VALUE_RANGE: 1::11;-9 |
VALUE_RANGE: 1 :: 11;-9;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_action__2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action__2' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_action__3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action__3' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_causality |
NEW_MAP_ELEMENT |
|
Added data element 'ae_causality' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_stopdate_known |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stopdate_known' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_stopdate_unknown |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stopdate_unknown' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_yesno |
NEW_MAP_ELEMENT |
|
Added data element 'ae_yesno' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
eventname |
NEW_MAP_ELEMENT |
|
Added data element 'eventname' to data structure 'adev01'. |
08/16/2023 09:20 AM
|
ae_action__2 |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
ae_action__3 |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
ae_causality |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
ae_stopdate_known |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
ae_stopdate_unknown |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
ae_yesno |
NEW_DATA_ELEMENT |
|
|
08/16/2023 09:19 AM
|
angina |
NEW_MAP_ELEMENT |
|
Added data element 'angina' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
anginadays |
NEW_MAP_ELEMENT |
|
Added data element 'anginadays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
blisters |
NEW_MAP_ELEMENT |
|
Added data element 'blisters' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
blistersdays |
NEW_MAP_ELEMENT |
|
Added data element 'blistersdays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
chafing |
NEW_MAP_ELEMENT |
|
Added data element 'chafing' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
chafingdays |
NEW_MAP_ELEMENT |
|
Added data element 'chafingdays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
dyspnea |
NEW_MAP_ELEMENT |
|
Added data element 'dyspnea' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
dyspneadays |
NEW_MAP_ELEMENT |
|
Added data element 'dyspneadays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
falls |
NEW_MAP_ELEMENT |
|
Added data element 'falls' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
fatigue_v2 |
NEW_MAP_ELEMENT |
|
Added data element 'fatigue_v2' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
fatiguedays |
NEW_MAP_ELEMENT |
|
Added data element 'fatiguedays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
joint |
NEW_MAP_ELEMENT |
|
Added data element 'joint' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
jointdays |
NEW_MAP_ELEMENT |
|
Added data element 'jointdays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
soreness |
NEW_MAP_ELEMENT |
|
Added data element 'soreness' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
sorenessdays |
NEW_MAP_ELEMENT |
|
Added data element 'sorenessdays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
strain |
NEW_MAP_ELEMENT |
|
Added data element 'strain' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
straindays |
NEW_MAP_ELEMENT |
|
Added data element 'straindays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
fallsdays |
NEW_MAP_ELEMENT |
|
Added data element 'fallsdays' to data structure 'adev01'. |
05/16/2023 16:50 PM
|
angina |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
anginadays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
blisters |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
blistersdays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
chafing |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
chafingdays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
dyspnea |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
dyspneadays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
fallsdays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
fatigue_v2 |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
fatiguedays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
joint |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
jointdays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
soreness |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
sorenessdays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
strain |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
straindays |
NEW_DATA_ELEMENT |
|
|
05/16/2023 16:50 PM
|
aef001 |
NOTES, |
NOTES: -9=unknown |
NOTES: -9=unknown |
04/18/2023 11:34 AM
|
stage |
NOTES, |
NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
|
NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing; |
04/18/2023 11:34 AM
|
ae |
ELEMENT_SIZE, |
ELEMENT_SIZE: 500 |
ELEMENT_SIZE: 4000 |
04/17/2023 14:18 PM
|
ae_hosp |
NEW_MAP_ELEMENT |
|
Added data element 'ae_hosp' to data structure 'adev01'. |
04/17/2023 12:47 PM
|
ae_hospcmts |
NEW_MAP_ELEMENT |
|
Added data element 'ae_hospcmts' to data structure 'adev01'. |
04/17/2023 12:47 PM
|
ae_hosp |
NEW_DATA_ELEMENT |
|
|
04/17/2023 12:47 PM
|
ae_hospcmts |
NEW_DATA_ELEMENT |
|
|
04/17/2023 12:47 PM
|
drughold |
NEW_MAP_ELEMENT |
|
Added data element 'drughold' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
drugreduce |
NEW_MAP_ELEMENT |
|
Added data element 'drugreduce' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
eventnum |
NEW_MAP_ELEMENT |
|
Added data element 'eventnum' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
history |
NEW_MAP_ELEMENT |
|
Added data element 'history' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
intensity |
NEW_MAP_ELEMENT |
|
Added data element 'intensity' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
outcomeintervention |
NEW_MAP_ELEMENT |
|
Added data element 'outcomeintervention' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
outcomemedicalevent |
NEW_MAP_ELEMENT |
|
Added data element 'outcomemedicalevent' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
resolution |
NEW_MAP_ELEMENT |
|
Added data element 'resolution' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
terminated |
NEW_MAP_ELEMENT |
|
Added data element 'terminated' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
tests |
NEW_MAP_ELEMENT |
|
Added data element 'tests' to data structure 'adev01'. |
03/07/2023 14:56 PM
|
drughold |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
drugreduce |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
eventnum |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
history |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
outcomeintervention |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
outcomemedicalevent |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
resolution |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
terminated |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 PM
|
tests |
NEW_DATA_ELEMENT |
|
|
03/07/2023 14:56 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
|
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
|
adv_action_desc |
NEW_MAP_ELEMENT |
|
Added data element 'adv_action_desc' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelat1_spec |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelat1_spec' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelat2_spec |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelat2_spec' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelat3_spec |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelat3_spec' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelat4_spec |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelat4_spec' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelat5_spec |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelat5_spec' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_notrelate |
NEW_MAP_ELEMENT |
|
Added data element 'adv_notrelate' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_outcome_othr |
NEW_MAP_ELEMENT |
|
Added data element 'adv_outcome_othr' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_reporting |
NEW_MAP_ELEMENT |
|
Added data element 'adv_reporting' to data structure 'adev01'. |
09/06/2022 09:52 AM
|
adv_action_desc |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelat1_spec |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelat2_spec |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelat3_spec |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelat4_spec |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelat5_spec |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_notrelate |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_outcome_othr |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
adv_reporting |
NEW_DATA_ELEMENT |
|
|
09/06/2022 09:52 AM
|
validity |
DESCRIPTION |
DESCRIPTION: Valdity rating |
DESCRIPTION: Validity rating |
07/05/2022 16:20 PM
|
ae_unantic |
NEW_MAP_ELEMENT |
|
Added data element 'ae_unantic' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
dsmbrprtcmts |
NEW_MAP_ELEMENT |
|
Added data element 'dsmbrprtcmts' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
dsmbrpt |
NEW_MAP_ELEMENT |
|
Added data element 'dsmbrpt' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
fdarptcmt |
NEW_MAP_ELEMENT |
|
Added data element 'fdarptcmt' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
immcmts |
NEW_MAP_ELEMENT |
|
Added data element 'immcmts' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
immrpt |
NEW_MAP_ELEMENT |
|
Added data element 'immrpt' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
immrptdt |
NEW_MAP_ELEMENT |
|
Added data element 'immrptdt' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
irbrprtcmts |
NEW_MAP_ELEMENT |
|
Added data element 'irbrprtcmts' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
irbrpt |
NEW_MAP_ELEMENT |
|
Added data element 'irbrpt' to data structure 'adev01'. |
05/20/2022 16:43 PM
|
ae_unantic |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
dsmbrprtcmts |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
dsmbrpt |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
fdarptcmt |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
immcmts |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
immrpt |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
immrptdt |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
irbrprtcmts |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
irbrpt |
NEW_DATA_ELEMENT |
|
|
05/20/2022 16:42 PM
|
aescode |
NOTES, |
NOTES: |
NOTES: 999= Missing Data |
03/25/2022 13:57 PM
|
ae_dischdt |
NEW_MAP_ELEMENT |
|
Added data element 'ae_dischdt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
ae_hospdt |
NEW_MAP_ELEMENT |
|
Added data element 'ae_hospdt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
ae_lrnddt |
NEW_MAP_ELEMENT |
|
Added data element 'ae_lrnddt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
ae_pidt |
NEW_MAP_ELEMENT |
|
Added data element 'ae_pidt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
aeaction |
NEW_MAP_ELEMENT |
|
Added data element 'aeaction' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
aenci |
NEW_MAP_ELEMENT |
|
Added data element 'aenci' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
aerel_drug |
NEW_MAP_ELEMENT |
|
Added data element 'aerel_drug' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
aerel_part |
NEW_MAP_ELEMENT |
|
Added data element 'aerel_part' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
fdarprt |
NEW_MAP_ELEMENT |
|
Added data element 'fdarprt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
fdarprtdt |
NEW_MAP_ELEMENT |
|
Added data element 'fdarprtdt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
dsmbrprtdt |
NEW_MAP_ELEMENT |
|
Added data element 'dsmbrprtdt' to data structure 'adev01'. |
11/19/2021 08:42 AM
|
ae_dischdt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
ae_hospdt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
ae_lrnddt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
ae_pidt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
aeaction |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
aenci |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
aerel_drug |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
aerel_part |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
fdarprt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
fdarprtdt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
dsmbrprtdt |
NEW_DATA_ELEMENT |
|
|
11/19/2021 08:41 AM
|
sex |
DESCRIPTION |
DESCRIPTION: Sex of the subject |
DESCRIPTION: Sex of subject at birth |
07/09/2021 10:38 AM
|
ae_age |
NEW_MAP_ELEMENT |
|
Added data element 'ae_age' to data structure 'adev01'. |
07/08/2021 15:38 PM
|
aefollowup_age |
NEW_MAP_ELEMENT |
|
Added data element 'aefollowup_age' to data structure 'adev01'. |
07/08/2021 15:38 PM
|
aereport_age |
NEW_MAP_ELEMENT |
|
Added data element 'aereport_age' to data structure 'adev01'. |
07/08/2021 15:38 PM
|
aeresolved_age |
NEW_MAP_ELEMENT |
|
Added data element 'aeresolved_age' to data structure 'adev01'. |
07/08/2021 15:38 PM
|
primaryorsecondary |
NEW_MAP_ELEMENT |
|
Added data element 'primaryorsecondary' to data structure 'adev01'. |
07/08/2021 15:38 PM
|
ae_age |
NEW_DATA_ELEMENT |
|
|
07/08/2021 15:38 PM
|
aefollowup_age |
NEW_DATA_ELEMENT |
|
|
07/08/2021 15:38 PM
|
aereport_age |
NEW_DATA_ELEMENT |
|
|
07/08/2021 15:38 PM
|
aeresolved_age |
NEW_DATA_ELEMENT |
|
|
07/08/2021 15:38 PM
|
primaryorsecondary |
NEW_DATA_ELEMENT |
|
|
07/08/2021 15:38 PM
|
aae02 |
NEW_MAP_ELEMENT |
|
Added data element 'aae02' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae03 |
NEW_MAP_ELEMENT |
|
Added data element 'aae03' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae04 |
NEW_MAP_ELEMENT |
|
Added data element 'aae04' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae05 |
NEW_MAP_ELEMENT |
|
Added data element 'aae05' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae06 |
NEW_MAP_ELEMENT |
|
Added data element 'aae06' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae01 |
NEW_MAP_ELEMENT |
|
Added data element 'aae01' to data structure 'adev01'. |
03/02/2021 10:28 AM
|
aae01 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
aae02 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
aae03 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
aae04 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
aae05 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
aae06 |
NEW_DATA_ELEMENT |
|
|
03/02/2021 10:28 AM
|
falls |
NEW_DATA_ELEMENT |
|
|
02/04/2021 15:47 PM
|
study |
DESCRIPTION |
DESCRIPTION: Study |
DESCRIPTION: Study; The code for each individual study |
01/11/2021 08:51 AM
|
interview_date |
NOTES, |
NOTES: Required field |
NOTES: |
01/08/2021 10:21 AM
|
ae33 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
ae17 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
ae21 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
ae25 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
ae29 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
ae13 |
NEW_TRANSLATION_RULE |
|
2 = 0 |
09/29/2020 12:27 PM
|
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
|
aecat |
NOTES, |
NOTES: 1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin |
NOTES: 1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculoskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin ; 14 = Congenital, Familial and Genetic Disorders ; 15 = Ear and Labyrinth Disorders ; 16 = Endocrine Disorders ; 17 = Eye Disorders ; 18 = Hepatobiliary Disorders ; 19 = Immune System Disorders ; 20 = Infections and Infestations ; 21 = Injury, Poisoning and Procedural Complications ; 22 = Investigations ; 23 = Metabolism and Nutrition Disorders ; 24 = Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps) ; 25 = Nervous System Disorders ; 26 = Pregnancy, Puerperium and Perinatal Conditions ; 27 = Product Issues ; 28 = Renal and Urinary Disorders ; 29 = Reproductive System and Breast Disorders ; 30 = Respiratory, Thoracic and Mediastinal Disorders ; 31 = Social Circumstances ; 32 = Surgical and Medical Procedures ; 33 = Vascular Disorders |
09/29/2020 12:23 PM
|
aecat |
VALUE_RANGE, |
VALUE_RANGE: 1::13 |
VALUE_RANGE: 1::33 |
09/29/2020 12:23 PM
|
ae13 |
NEW_MAP_ELEMENT |
|
Added data element 'ae13' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae14 |
NEW_MAP_ELEMENT |
|
Added data element 'ae14' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae15 |
NEW_MAP_ELEMENT |
|
Added data element 'ae15' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae16 |
NEW_MAP_ELEMENT |
|
Added data element 'ae16' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae17 |
NEW_MAP_ELEMENT |
|
Added data element 'ae17' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae18 |
NEW_MAP_ELEMENT |
|
Added data element 'ae18' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae19 |
NEW_MAP_ELEMENT |
|
Added data element 'ae19' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae30 |
NEW_MAP_ELEMENT |
|
Added data element 'ae30' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae31 |
NEW_MAP_ELEMENT |
|
Added data element 'ae31' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae32 |
NEW_MAP_ELEMENT |
|
Added data element 'ae32' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae33 |
NEW_MAP_ELEMENT |
|
Added data element 'ae33' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae20 |
NEW_MAP_ELEMENT |
|
Added data element 'ae20' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae21 |
NEW_MAP_ELEMENT |
|
Added data element 'ae21' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae22 |
NEW_MAP_ELEMENT |
|
Added data element 'ae22' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae23 |
NEW_MAP_ELEMENT |
|
Added data element 'ae23' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae24 |
NEW_MAP_ELEMENT |
|
Added data element 'ae24' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae25 |
NEW_MAP_ELEMENT |
|
Added data element 'ae25' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae26 |
NEW_MAP_ELEMENT |
|
Added data element 'ae26' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae27 |
NEW_MAP_ELEMENT |
|
Added data element 'ae27' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae28 |
NEW_MAP_ELEMENT |
|
Added data element 'ae28' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae29 |
NEW_MAP_ELEMENT |
|
Added data element 'ae29' to data structure 'adev01'. |
09/29/2020 10:38 AM
|
ae13 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae14 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae15 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae16 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae17 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae18 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae19 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae20 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae21 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae22 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae23 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae24 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae25 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae26 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae27 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae28 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae29 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae30 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae31 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae32 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
ae33 |
NEW_DATA_ELEMENT |
|
|
09/29/2020 10:38 AM
|
bkgrnd_diag |
ELEMENT_SIZE, |
ELEMENT_SIZE: 255 |
ELEMENT_SIZE: 1020 |
09/22/2020 12:13 PM
|
description_of_sae |
ELEMENT_SIZE, |
ELEMENT_SIZE: 300 |
ELEMENT_SIZE: 800 |
06/25/2020 15:06 PM
|
visit |
ELEMENT_SIZE, |
ELEMENT_SIZE: 50 |
ELEMENT_SIZE: 60 |
06/25/2020 10:25 AM
|
resp_source |
NEW_MAP_ELEMENT |
|
Added data element 'resp_source' to data structure 'adev01'. |
03/26/2020 12:05 PM
|
version_form |
ELEMENT_SIZE, |
ELEMENT_SIZE: 100 |
ELEMENT_SIZE: 121 |
03/25/2020 12:57 PM
|
resp_source |
NEW_DATA_ELEMENT |
|
|
03/23/2020 15:13 PM
|
aef008 |
NOTES, |
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown |
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); 7= Physiotherapy; 8= Hospitalization and medicine; 9= Physiotherapy and medicine; 10= Hospitalization and physio; 11= Hospitalization, medicine, and physio; -9=unknown |
03/02/2020 16:33 PM
|
aef008 |
VALUE_RANGE, |
VALUE_RANGE: 1::6; -9 |
VALUE_RANGE: 1::11;-9 |
03/02/2020 16:31 PM
|
ae_flareup |
NEW_MAP_ELEMENT |
|
Added data element 'ae_flareup' to data structure 'adev01'. |
03/02/2020 16:26 PM
|
ae_flareup |
NEW_DATA_ELEMENT |
|
|
03/02/2020 16:26 PM
|
sex |
NEW_TRANSLATION_RULE |
|
1 = F |
03/02/2020 13:29 PM
|
sex |
NEW_TRANSLATION_RULE |
|
0 = M |
03/02/2020 13:29 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
|
update |
NOTES, |
NOTES: 1=Updated |
NOTES: 1= yes; 0= no |
01/08/2020 19:28 PM
|
validity |
NEW_MAP_ELEMENT |
|
Added data element 'validity' to data structure 'adev01'. |
12/03/2019 17:17 PM
|
validity |
NEW_DATA_ELEMENT |
|
|
11/22/2019 11:47 AM
|
bkgrnd_diag |
DESCRIPTION |
DESCRIPTION: Diagnosis |
DESCRIPTION: Diagnosis. Provided by parent |
09/11/2019 15:06 PM
|
sped3_11 |
NOTES, |
NOTES: |
NOTES: 999=NA/NK/missing |
07/11/2019 12:45 PM
|
gender |
PERMANENTLY ALIASED |
gender |
sex |
04/22/2019 00:00 AM
|
site |
ELEMENT_SIZE, |
ELEMENT_SIZE: 100 |
ELEMENT_SIZE: 101 |
01/30/2019 17:56 PM
|
aeexp |
NEW_TRANSLATION_RULE |
|
2 = 0 |
01/09/2019 12:00 PM
|
aeser |
NEW_TRANSLATION_RULE |
|
2 = 0 |
01/09/2019 12:00 PM
|
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
|
visit |
NOTES, |
NOTES: Character description of each type of visit |
NOTES: |
07/18/2018 13:11 PM
|
ae_action_taken_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_event_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_event_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_event_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_event_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_8 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_8' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_9 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_9' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_event_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_event_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_event_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_event_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_event_7 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_event_7' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_expected_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_expected_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_outcome_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_outcome_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_sae_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_sae_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_severity_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_severity_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_start_date_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_start_date_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_3' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_4 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_4' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_5 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_5' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_6 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_6' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_action_taken_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_action_taken_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_action_taken_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_event_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_event_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_event_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_event_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_event_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_expected_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_outcome_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_relation_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_relation_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_relation_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_sae_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_severity_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_start_date_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_2 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_2 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_stop_date_2' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
ae_stop_date_3 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_4 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_5 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_6 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_7 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_8 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
ae_stop_date_9 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
any_other_aes_to_report_1 |
NEW_DATA_ELEMENT |
|
|
07/06/2018 10:50 AM
|
any_other_aes_to_report_1 |
NEW_MAP_ELEMENT |
|
Added data element 'any_other_aes_to_report_1' to data structure 'adev01'. |
07/06/2018 10:50 AM
|
causedis |
NEW_TRANSLATION_RULE |
|
PRIMARY DISEASE UNDER STUDY = 1 |
05/31/2018 13:28 PM
|
ratrel |
ELEMENT_SIZE, |
ELEMENT_SIZE: 100 |
ELEMENT_SIZE: 250 |
05/30/2018 14:05 PM
|
sefgass16 |
VALUE_RANGE, , NOTES, |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
VALUE_RANGE: 0::3; -9; 9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated; |
05/11/2018 14:05 PM
|
sefgens49 |
VALUE_RANGE, , NOTES, |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; 9; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown |
05/11/2018 14:05 PM
|
sefoths61 |
VALUE_RANGE, , NOTES, |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; 9; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown |
05/11/2018 14:05 PM
|
aef001 |
VALUE_RANGE, |
VALUE_RANGE: 1::99; -9 |
VALUE_RANGE: |
05/04/2018 11:31 AM
|
aeacn |
NEW_TRANSLATION_RULE |
|
DRUG INTERRUPTED = 6 |
05/04/2018 11:05 AM
|
aeacn |
NEW_TRANSLATION_RULE |
|
DRUG PERMANENTLY DISCONTINUED = 2 |
05/04/2018 11:05 AM
|
ae_serious_signific |
NEW_TRANSLATION_RULE |
|
IMPORTANT MEDICAL EVENT = 1 |
05/03/2018 11:15 AM
|
defect |
NEW_TRANSLATION_RULE |
|
CONGENITAL ANOMALY OR BIRTH DEFECT = 1 |
05/03/2018 11:15 AM
|
dsabl |
NEW_TRANSLATION_RULE |
|
PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY = 1 |
05/03/2018 11:15 AM
|
saedispd |
NEW_TRANSLATION_RULE |
|
UNK = NK |
05/03/2018 11:15 AM
|
altnone |
NEW_TRANSLATION_RULE |
|
NONE = 1 |
05/03/2018 11:15 AM
|
altothr |
NEW_TRANSLATION_RULE |
|
OTHER KNOWN OR SUSPECTED CAUSE = 1 |
05/03/2018 11:15 AM
|
death |
NEW_TRANSLATION_RULE |
|
DEATH = 1 |
05/03/2018 11:15 AM
|
hsptl |
NEW_TRANSLATION_RULE |
|
REQUIRE INPATIENT HOSP OR PROLONGATION OF EXISTING HOSP = 1 |
05/03/2018 11:15 AM
|
lfthr |
NEW_TRANSLATION_RULE |
|
LIFE-THREATENING = 1 |
05/03/2018 11:15 AM
|
altillns |
NEW_TRANSLATION_RULE |
|
CONCOMITANT ILLNESS = 1 |
05/03/2018 11:15 AM
|
altproc |
NEW_TRANSLATION_RULE |
|
STUDY PROCEDURE = 1 |
05/03/2018 11:15 AM
|
causecon |
NEW_TRANSLATION_RULE |
|
CONCOMITANT MEDICATION = 1 |
05/03/2018 11:15 AM
|
causedis |
NEW_TRANSLATION_RULE |
|
PRIMARY DISEASE UNDER STUDY� = 1 |
05/03/2018 11:15 AM
|
aeser |
NEW_TRANSLATION_RULE |
|
Y = 1 |
05/03/2018 11:15 AM
|
aeser |
NEW_TRANSLATION_RULE |
|
N = 0 |
05/03/2018 11:15 AM
|
studyrelation_1 |
NEW_TRANSLATION_RULE |
|
POSSIBLY RELATED = 3 |
05/03/2018 11:15 AM
|
studyrelation_1 |
NEW_TRANSLATION_RULE |
|
DEFINITELY RELATED = 1 |
05/03/2018 11:15 AM
|
studyrelation_1 |
NEW_TRANSLATION_RULE |
|
PROBABLY RELATED = 2 |
05/03/2018 11:15 AM
|
aesev |
NEW_TRANSLATION_RULE |
|
MODERATE = 2 |
05/03/2018 11:15 AM
|
aesev |
NEW_TRANSLATION_RULE |
|
SEVERE = 3 |
05/03/2018 11:15 AM
|
studyrelation_1 |
NEW_TRANSLATION_RULE |
|
NOT RELATED = 5 |
05/03/2018 11:15 AM
|
studyrelation_1 |
NEW_TRANSLATION_RULE |
|
UNLIKELY RELATED = 4 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
NOT RECOVERED/NOT RESOLVED = 13 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
UNK = -9 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
FATAL = 4 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
RECOVERED/RESOLVED WITH SEQUELAE = 14 |
05/03/2018 11:15 AM
|
aesev |
NEW_TRANSLATION_RULE |
|
MILD = 1 |
05/03/2018 11:15 AM
|
aeongo |
NEW_TRANSLATION_RULE |
|
ONGOING = 1 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
RECOVERED/RESOLVED = 17 |
05/03/2018 11:15 AM
|
aeout |
NEW_TRANSLATION_RULE |
|
RECOVERING/RESOLVING = 18 |
05/03/2018 11:15 AM
|
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
|
saedispd |
VALUE_RANGE, |
VALUE_RANGE: Y;N |
VALUE_RANGE: Y;N; NK; NA |
05/02/2018 17:31 PM
|
ae_serious_signific |
VALUE_RANGE, , NOTES, |
VALUE_RANGE:
NOTES: |
VALUE_RANGE: 0;1
NOTES: 0 = No; 1 = Yes |
05/02/2018 17:31 PM
|
none |
NEW_MAP_ELEMENT |
|
Added data element 'none' to data structure 'adev01'. |
03/19/2018 15:44 PM
|
therapyp |
NEW_MAP_ELEMENT |
|
Added data element 'therapyp' to data structure 'adev01'. |
03/19/2018 15:44 PM
|
wk6c11a |
NEW_MAP_ELEMENT |
|
Added data element 'wk6c11a' to data structure 'adev01'. |
03/19/2018 15:44 PM
|
yr_treat1_ended |
NEW_MAP_ELEMENT |
|
Added data element 'yr_treat1_ended' to data structure 'adev01'. |
03/19/2018 15:44 PM
|
completed |
VALUE_RANGE, , NOTES, |
VALUE_RANGE: 0::2
NOTES: 0=No; 1=Yes; 2=Yes, lost |
VALUE_RANGE: 0::3
NOTES: 0=No; 1=Yes; 2=Yes, lost; 3=Unverified |
01/26/2018 12:16 PM
|
eventname |
NEW_DATA_ELEMENT |
|
|
11/30/2017 12:26 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
|
ayen |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0 = No; 1 = Yes |
VALUE_RANGE: 0;1;-9
NOTES: 0 = No; 1 = Yes; -9 = Did not inquire |
08/28/2017 12:15 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
|
saps_ad10 |
NOTES |
NOTES: 99 = Missing |
NOTES: |
06/02/2017 11:32 AM
|
saps_ad10 |
NOTES |
NOTES: |
NOTES: 99 = Missing |
06/02/2017 11:32 AM
|
completed |
DESCRIPTION |
DESCRIPTION: Checks if form is completed |
DESCRIPTION: Checks if completed |
04/11/2017 12:29 PM
|
completed |
VALUE_RANGE |
VALUE_RANGE: 0:2 |
VALUE_RANGE: 0::2 |
03/16/2017 17:11 PM
|
completed |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0=No; 1=Yes |
VALUE_RANGE: 0:2
NOTES: 0=No; 1=Yes; 2=Yes, lost |
03/16/2017 16:33 PM
|
yr_treat1_ended |
NEW_DATA_ELEMENT |
|
|
03/14/2017 10:49 AM
|
sdatothr |
ELEMENT_SIZE |
ELEMENT_SIZE: 60 |
ELEMENT_SIZE: 250 |
02/10/2017 15:37 PM
|
ae |
ELEMENT_SIZE |
ELEMENT_SIZE: 100 |
ELEMENT_SIZE: 250 |
02/10/2017 15:37 PM
|
adverse_event_code |
VALUE_RANGE |
VALUE_RANGE: 1::26 |
VALUE_RANGE: 1::126 |
02/09/2017 16:22 PM
|
adverse_event_code |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::74
NOTES: 1 = Psychic Side Effects-UKU: Concentration;
2 = Psychic Side Effects-UKU: Asthenia/Lassitude/ Increased Fatigability;
3 = Psychic Side Effects-UKU: Sleepiness/Sedation;
4 = Psychic Side Effects-UKU: Failing Memory;
5 = Psychic Side Effects-UKU: Tension/Unrest;
6 = Psychic Side Effects-UKU: Increased Sleep;
7 = Psychic Side Effects-UKU: Decreased Sleep;
8 = Psychic Side Effects-UKU: Increased Dream Activity;
9 = Psychic Side Effects-UKU: Emotional Indifference "10 = Neurological-UKU: Dystonia;
11 = Neurological-UKU: Rigidity;
12 = Neurological-UKU: Hypokinesia/Akinesia;
13 = Neurological-UKU: Hyperkinesia;
14 = Neurological-UKU: Tremor;
15 = Neurological-UKU: Akathisia;
16 = Neurological-UKU: Seizures;
17 = Neurological-UKU: Paraesthesias;
18 = Neurological-UKU: Headache" "19 = Autonomic Side Effects-UKU: Accommodation Disturbances;
20 = Autonomic Side Effects-UKU: Increased Salivation;
21 = Autonomic Side Effects-UKU: Reduced Salivation (Dry Mouth);
22 = Autonomic Side Effects-UKU: Nausea/Vomiting;
23 = Autonomic Side Effects-UKU: Diarrhea;
24 = Autonomic Side Effects-UKU: Constipation;
25 = Autonomic Side Effects-UKU: Micturition Disturbances;
26 = Autonomic Side Effects-UKU: Polyuria/Polydipsia;
27 = Autonomic Side Effects-UKU: Orthostatic Dizziness;
28 = Autonomic Side Effects-UKU: Palpitations/Tachycardia;
29 = Autonomic Side Effects-UKU: Increased Tendency to sweat""30 = Skin -UKU: Rash;
31 = Skin -UKU: Pruritis;
32 = Skin -UKU: Photosensitivity;
33 = Skin -UKU: Increased Pigmentation;
34 = Weight-UKU: Weight Gain;
35 = Weight-UKU: Weight Loss""36 = Genitourinary-UKU: Menorrhagia;
37 = Genitourinary-UKU: Amenorrhea;
38 = Genitourinary-UKU: Galactorrhea;
39 = Genitourinary-UKU: Breast enlargement;
40 = Genitourinary-UKU: Increased Sexual Desire;
41 = Genitourinary-UKU: Decreased Sexual Desire;
42 = Genitourinary-UKU: Erectile Dysfunction;
43 = Genitourinary-UKU: Ejaculatory Dysfunction;
44 = Genitourinary-UKU: Orgastic Dysfunction;
45 = Genitourinary-UKU: Dry Vagina""46 = Psychological/Behavioral: Increased motor activity,
including activation and hyperactivity;
47 = Psychological/Behavioral: Decreased motor activity;
48 = Psychological/Behavioral: Slurred speech;
49 = Psychological/Behavioral: Confusion;
50 = Psychological/Behavioral: Significant worsening of anxiety
or development of anxiety not present at baseline;
51 = Psychological/Behavioral: Suicide gesture/attempt;
52 = Psychological/Behavioral: Suicide completion;
53 = Psychological/Behavioral: Aggression;
54 = Psychological/Behavioral: Development of hallucinations""55 = Other: Fever;
56 = Other: Psychiatric hospitalization due to worsening condition;
57 = Other: Death (not due to suicide);
58 = Other: Fall;
59 = Other: Accidental Injury;
60 = Other: Pedal edema/edema;
61 = Other: Ecchymosis;
62 = Other: Dizziness/faintness;
63 = Other: Loss of consciousness;
64 = Other: Bradychardia""65 = Other: Muscle/bone/joint pain/condition;
66 = Other: Hair problems;
67 = Other: Medical or Surgical Procedure;
68 = Other: Chest Pain;
69 = Other: Heart attack;
70 = Other: Development or exacerbation of asthma;
71 = Other: Change in study lab values requiring medical intervention;
72 = Other: NMS;
73 = Other: Allergies, Not Otherwise Specified (elicit specific reaction and code using symptomatology. If no other code is applicable, use this code.);
74 = Other" |
VALUE_RANGE: 1::26
NOTES: 1 = Concentration; 2 = Asthenia/Lassitude/ Increased Fatigability; 3 = Sleepiness/Sedation; 4 = Failing Memory; 5 = Tension/Unrest; 6 = Increased Sleep; 7 = Decreased Sleep; 8 = Increased Dream Activity; 9 = Emotional Indifference; 10 = Dystonia; 11 = Rigidity; 12 = Hypokinesia/Akinesia; 13 = Hyperkinesia; 14 = Tremor; 15 = Akathisia; 16 = Seizures; 17 = Paraesthesias; 18 = Headache;19 = Accommodation Disturbances; 20 = Increased Salivation; 21 = Reduced Salivation (Dry Mouth); 22 = Nausea/Vomiting; 23 = Diarrhea; 24 = Constipation; 25 = Micturition Disturbances; 26 = Polyuria/Polydipsia; 27 = Orthostatic Dizziness; 28 = Palpitations/Tachycardia; 29 = Increased Tendency to sweat; 30 = Skin -UKU: Rash; 31 = Skin -UKU: Pruritis; 32 = Skin -UKU: Photosensitivity; 33 = Skin -UKU: Increased Pigmentation; 34 = Weight-UKU: Weight Gain; 35 = Weight-UKU: Weight Loss; 36 = Genitourinary-UKU: Menorrhagia; 37 = Genitourinary-UKU: Amenorrhea; 38 = Genitourinary-UKU: Galactorrhea; 39 = Genitourinary-UKU: Breast enlargement; 40 = Genitourinary-UKU: Increased Sexual Desire; 41 = Genitourinary-UKU: Decreased Sexual Desire; 42 = Genitourinary-UKU: Erectile Dysfunction; 43 = Genitourinary-UKU: Ejaculatory Dysfunction;44 = Genitourinary-UKU: Orgastic Dysfunction; 45 = Genitourinary-UKU: Dry Vagina;46 = Psychological/Behavioral: Increased motor activity, including activation and hyperactivity; 47 = Psychological/Behavioral: Decreased motor activity; 48 = Psychological/Behavioral: Slurred speech; 49 = Psychological/Behavioral: Confusion; 50 = Psychological/Behavioral: Significant worsening of anxiety or development of anxiety not present at baseline; 51 = Psychological/Behavioral: Suicide gesture/attempt; 52 = Psychological/Behavioral: Suicide completion; 53 = Psychological/Behavioral: Aggression; 54 = Psychological/Behavioral: Development of hallucinations; 55 = Fever; 56 = Psychiatric hospitalization due to worsening condition; 57 = Death (not due to suicide); 58 = Fall; 59 = Accidental Injury; 60 = Pedal edema/edema; 61 = Ecchymosis; 62 = Dizziness/faintness; 63 = Loss of consciousness; 64 = Bradychardia;65 = Muscle/bone/joint pain/condition; 66 = Hair problems; 67 = Medical or Surgical Procedure; 68 = Chest Pain; 69 = Heart attack; 70 = Development or exacerbation of asthma; 71 = Change in study lab values requiring medical intervention; 72 = NMS; 73 = Allergies, Not Otherwise Specified (elicit specific reaction and code using symptomatology. If no other code is applicable, use this code.); 74 = Other;75=Flu or Upper Respiratory Problems, including Bronchitis; 76=Stomach or abdominal discomfort, including "nervous stomach" and abdominal cramps, but not menstrual cramps; 77=Tiredness/fatigue; 78=Hallucinations; 79=Difficulty falling asleep; 80=Repetitive Behavior or Thoughts; 81=Nasal congestion or Cold; 82=Appetite decrease; 83=Tic movements; 84=Irritability; 85=Anxiety; 86=Emotional Outburst/Mood Lability; 87=Coughing; 88=Disinhibition, including behavioral disinhibition; 89=Epistaxis/nosebleed; 90=Abnormal Lab Result: includes anemia; 91=Painful urination; 92=Depression; 93=Dermatologic problems; 94=Not Otherwise Listed (or Unknown); 95=Enuresis; 96=Hypertension; 97=Oppositional Behavior; 98=Shortness of breath; 99=Fever; 100=Withdrawn/Spacey/"Zombie-like"; 101=Dental problems; 102=Difficulty swallowing; 103=Viral Syndrome, includes infectious diseases; 104=Dyskinesia; 105=Muscle/bone/joint pain/condition; 106=Aggression; 107=Early morning awakening; 108=Interrupted sleep/Other Sleep Problems; 110=Sore throat; 111=Tachycardia; 112=Over-Talkativeness; 113=Eye irritation; 114=Ear ache/Otitis, including ear fluid; 115=Mouth Ulcer; 116=Blurred vision; 117=Tinnitus; 118=Poor hearing; 119=Increased thirst; 120=Hyperacusis: sensory sensitivity or oversensitivity; 121=Over focused; 122=Stammering/Stuttering; verbal dysfluency; 123=Medication Rebound; 124=Restlessness/Agitation, including fidgety; 125=Sore tongue; 126=Genital discomfort |
02/09/2017 16:22 PM
|
causesdr |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0= No; 1 = At least possibly related |
VALUE_RANGE: 0::8
NOTES: 0= No; 1 = At least possibly related;2=Dose response; 3=Dechallenge/rechallenge; 4=Timing of onset; 5=Seen in other patients in this trial; 6=Known drug effect; 7=Laboratory data; 8=Other |
02/08/2017 16:46 PM
|
aer_c |
NEW_DATA_ELEMENT |
|
|
02/08/2017 14:17 PM
|
aer_c |
NEW_MAP_ELEMENT |
|
Added data element 'aer_c' to data structure 'adev01'. |
02/08/2017 14:17 PM
|
aer_f |
NEW_DATA_ELEMENT |
|
|
02/08/2017 14:17 PM
|
aer_f |
NEW_MAP_ELEMENT |
|
Added data element 'aer_f' to data structure 'adev01'. |
02/08/2017 14:17 PM
|
aef005 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::7;9
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable; |
VALUE_RANGE: 1::9
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable;8=Medication Rebound
|
02/02/2017 16:38 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
|
aedur |
DESCRIPTION |
DESCRIPTION: AE duration (across all stages) � days |
DESCRIPTION: AE duration (across all stages) days |
02/02/2017 12:08 PM
|
leastsev |
DESCRIPTION |
DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1 |
02/02/2017 12:08 PM
|
mostsev |
DESCRIPTION |
DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1 |
02/02/2017 12:08 PM
|
lab020 |
DESCRIPTION |
DESCRIPTION: Date of PI signature |
DESCRIPTION: Date of PI/clinician signature |
01/17/2017 17:54 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
01/03/2017 13:55 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
01/03/2017 13:14 PM
|
withdrug |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0 = No;1 = Possibly;2 = Probably;3 = Definitely related |
VALUE_RANGE: 0::4; -9
NOTES: 0 = No;1 = Possibly;2 = Probably;3 = Definitely related; 4=Remotely; -9=NK |
12/29/2016 15:31 PM
|
excour |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::2
NOTES: 0=Intermittent; 1=Persistant; 2=Single occurance |
VALUE_RANGE: 0::4
NOTES: 0=Intermittent; 1=Persistant; 2=Single occurance;3=Intermittent, infrequently: <10 mins or <2x; 4=intermittent, frequently: >10 mins or >2x; |
12/28/2016 17:59 PM
|
aeacn |
VALUE_RANGE |
VALUE_RANGE: 1::10; 99 |
VALUE_RANGE: 1::10;99 |
12/28/2016 17:59 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
12/09/2016 15:17 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
12/09/2016 15:09 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
|
visnum |
NOTES |
NOTES: -1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; |
NOTES: -1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits |
12/05/2016 17:59 PM
|
studyrelation_1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 58::62; 69; -888; -999
NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; |
VALUE_RANGE: 1::5; 9; -888; -999
NOTES: 1=Definite; 2=Probable; 3=Possible; 4=Unlikely; 5=Unrelated; 9=Unknown; -888=Not Applicable; -999=Missing; |
12/05/2016 17:53 PM
|
description_of_sae |
ELEMENT_SIZE |
ELEMENT_SIZE: 250 |
ELEMENT_SIZE: 300 |
11/30/2016 11:19 AM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
11/07/2016 16:15 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
11/07/2016 16:10 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
11/07/2016 12:09 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
11/07/2016 11:16 AM
|
aesa14 |
ELEMENT_SIZE |
ELEMENT_SIZE: 200 |
ELEMENT_SIZE: |
10/31/2016 13:02 PM
|
gender |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
10/13/2016 13:26 PM
|
interview_age |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
10/13/2016 13:26 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
10/13/2016 13:26 PM
|
gender |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
10/13/2016 13:04 PM
|
interview_age |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
10/13/2016 13:04 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
10/13/2016 13:04 PM
|
meddra_status |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_status' to data structure 'adev01'. |
10/07/2016 15:56 PM
|
meddra_status |
TYPE, ELEMENT_SIZE |
TYPE: Integer
ELEMENT_SIZE: |
TYPE: String
ELEMENT_SIZE: 100 |
10/07/2016 15:55 PM
|
meddra_day |
POSITION |
POSITION: 368 |
POSITION: 367 |
10/07/2016 15:53 PM
|
meddra_hlgt_term |
POSITION |
POSITION: 357 |
POSITION: 356 |
10/07/2016 15:53 PM
|
meddra_hlt_code |
POSITION |
POSITION: 358 |
POSITION: 357 |
10/07/2016 15:53 PM
|
meddra_htl_term |
POSITION |
POSITION: 359 |
POSITION: 358 |
10/07/2016 15:53 PM
|
meddra_llt_code |
POSITION |
POSITION: 360 |
POSITION: 359 |
10/07/2016 15:53 PM
|
meddra_llt_term |
POSITION |
POSITION: 361 |
POSITION: 360 |
10/07/2016 15:53 PM
|
meddra_pt_code |
POSITION |
POSITION: 362 |
POSITION: 361 |
10/07/2016 15:53 PM
|
meddra_pt_term |
POSITION |
POSITION: 363 |
POSITION: 362 |
10/07/2016 15:53 PM
|
meddra_soc_code |
POSITION |
POSITION: 364 |
POSITION: 363 |
10/07/2016 15:53 PM
|
meddra_soc_term |
POSITION |
POSITION: 365 |
POSITION: 364 |
10/07/2016 15:53 PM
|
meddra_user_id |
POSITION |
POSITION: 366 |
POSITION: 365 |
10/07/2016 15:53 PM
|
meddra_version |
POSITION |
POSITION: 367 |
POSITION: 366 |
10/07/2016 15:53 PM
|
meddra_comment |
POSITION |
POSITION: 355 |
POSITION: 354 |
10/07/2016 15:53 PM
|
meddra_hlgt_code |
POSITION |
POSITION: 356 |
POSITION: 355 |
10/07/2016 15:53 PM
|
meddra_day |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_day' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_user_id |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_user_id' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_version |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_version' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_hlgt_term |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_hlgt_term' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_hlt_code |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_hlt_code' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_htl_term |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_htl_term' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_llt_code |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_llt_code' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_llt_term |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_llt_term' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_pt_code |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_pt_code' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_pt_term |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_pt_term' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_soc_code |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_soc_code' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_soc_term |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_soc_term' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_comment |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_comment' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_hlgt_code |
NEW_MAP_ELEMENT |
|
Added data element 'meddra_hlgt_code' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
ae_10 |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
ae_10 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_10' to data structure 'adev01'. |
10/06/2016 16:35 PM
|
meddra_comment |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_day |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_hlgt_code |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_hlgt_term |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_hlt_code |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_htl_term |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_llt_code |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_llt_term |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_pt_code |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_pt_term |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_soc_code |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_soc_term |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_status |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_user_id |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
meddra_version |
NEW_DATA_ELEMENT |
|
|
10/06/2016 16:35 PM
|
med_nm |
NEW_MAP_ELEMENT |
|
Added data element 'med_nm' to data structure 'adev01'. |
09/16/2016 14:37 PM
|
mtype |
NEW_MAP_ELEMENT |
|
Added data element 'mtype' to data structure 'adev01'. |
09/16/2016 14:37 PM
|
bg_curothmeds |
NEW_MAP_ELEMENT |
|
Added data element 'bg_curothmeds' to data structure 'adev01'. |
09/16/2016 14:37 PM
|
mtype |
DELETED_MAP_ELEMENT |
|
|
09/15/2016 18:27 PM
|
bg_curothmeds |
DELETED_MAP_ELEMENT |
|
|
09/15/2016 18:27 PM
|
med_nm |
DELETED_MAP_ELEMENT |
|
|
09/15/2016 18:27 PM
|
bg_curothmeds |
NEW_MAP_ELEMENT |
|
Added data element 'bg_curothmeds' to data structure 'aapc01'. |
09/15/2016 18:24 PM
|
med_nm |
NEW_MAP_ELEMENT |
|
Added data element 'med_nm' to data structure 'aapc01'. |
09/15/2016 18:24 PM
|
mtype |
NEW_MAP_ELEMENT |
|
Added data element 'mtype' to data structure 'aapc01'. |
09/15/2016 18:24 PM
|
mtype |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1;2
NOTES: 1=Li; 2=NTP |
VALUE_RANGE: 1::4
NOTES: 1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication |
09/15/2016 12:03 PM
|
action |
VALUE_RANGE, NOTES |
VALUE_RANGE: A; B; C;D; E; F; G;U
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown |
VALUE_RANGE: A; B; C;D; E; F; G;U; H
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown; H=Dose increased |
09/15/2016 12:02 PM
|
aeacn |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::5; 99
NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other |
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 |
08/30/2016 13:30 PM
|
aeout |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::12; -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 |
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 |
08/30/2016 13:30 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/25/2016 15:16 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/25/2016 15:08 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/19/2016 13:17 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/19/2016 13:08 PM
|
gender |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/11/2016 12:52 PM
|
interview_age |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/11/2016 12:52 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/11/2016 12:52 PM
|
gender |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/11/2016 12:26 PM
|
interview_age |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/11/2016 12:26 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/11/2016 12:26 PM
|
scid_event_age1 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age1' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age2 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age2' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age3 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age3' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age4 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age4' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age5 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age5' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age6 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age6' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age9 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age9' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_np114 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_np114' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_np116 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_np116' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
behavobs_mood |
NEW_MAP_ELEMENT |
|
Added data element 'behavobs_mood' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
bkgrnd_diag |
NEW_MAP_ELEMENT |
|
Added data element 'bkgrnd_diag' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
chartreview059 |
NEW_MAP_ELEMENT |
|
Added data element 'chartreview059' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
demo_health_condsp |
NEW_MAP_ELEMENT |
|
Added data element 'demo_health_condsp' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age7 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age7' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age8 |
NEW_MAP_ELEMENT |
|
Added data element 'scid_event_age8' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_event_age9 |
NEW_DATA_ELEMENT |
|
|
08/10/2016 11:07 AM
|
scid_np114 |
NEW_DATA_ELEMENT |
|
|
08/10/2016 11:07 AM
|
sped3_11 |
NEW_MAP_ELEMENT |
|
Added data element 'sped3_11' to data structure 'adev01'. |
08/10/2016 11:07 AM
|
scid_np116 |
NEW_DATA_ELEMENT |
|
|
08/10/2016 11:07 AM
|
cbcl1_2_text |
NEW_MAP_ELEMENT |
|
Added data element 'cbcl1_2_text' to data structure 'adev01'. |
07/15/2016 15:59 PM
|
sae_38 |
NEW_MAP_ELEMENT |
|
Added data element 'sae_38' to data structure 'adev01'. |
07/15/2016 15:59 PM
|
aes5 |
NEW_DATA_ELEMENT |
|
|
07/15/2016 15:59 PM
|
aes5 |
NEW_MAP_ELEMENT |
|
Added data element 'aes5' to data structure 'adev01'. |
07/15/2016 15:59 PM
|
sped3_11 |
ELEMENT_SIZE |
ELEMENT_SIZE: 100 |
ELEMENT_SIZE: 500 |
07/12/2016 15:34 PM
|
version_form |
ELEMENT_SIZE |
ELEMENT_SIZE: 20 |
ELEMENT_SIZE: 50 |
07/11/2016 14:45 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
06/23/2016 18:07 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
06/23/2016 17:45 PM
|
ae_maxm |
TYPE |
TYPE: Integer |
TYPE: Float |
06/23/2016 17:29 PM
|
ae_reld |
NEW_MAP_ELEMENT |
|
Added data element 'ae_reld' to data structure 'adev01'. |
06/23/2016 15:39 PM
|
ae_reld |
NEW_DATA_ELEMENT |
|
|
06/23/2016 15:39 PM
|
bg_curothmeds |
NEW_DATA_ELEMENT |
|
|
06/21/2016 15:29 PM
|
ae_maxa |
NOTES |
NOTES: 1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 � 4 |
NOTES: 1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 - 4 |
06/20/2016 10:49 AM
|
ae_maxa |
ELEMENT_SIZE |
ELEMENT_SIZE: 8 |
ELEMENT_SIZE: |
06/20/2016 10:48 AM
|
ae_maxm |
ELEMENT_SIZE |
ELEMENT_SIZE: 8 |
ELEMENT_SIZE: |
06/20/2016 10:48 AM
|
ae_intermit |
NEW_MAP_ELEMENT |
|
Added data element 'ae_intermit' to data structure 'adev01'. |
06/20/2016 10:47 AM
|
ae_maxa |
NEW_MAP_ELEMENT |
|
Added data element 'ae_maxa' to data structure 'adev01'. |
06/20/2016 10:47 AM
|
ae_maxm |
NEW_MAP_ELEMENT |
|
Added data element 'ae_maxm' to data structure 'adev01'. |
06/20/2016 10:47 AM
|
ae_descrip |
NEW_DATA_ELEMENT |
|
|
06/20/2016 10:47 AM
|
ae_descrip |
NEW_MAP_ELEMENT |
|
Added data element 'ae_descrip' to data structure 'adev01'. |
06/20/2016 10:47 AM
|
ae_maxa |
NEW_DATA_ELEMENT |
|
|
06/20/2016 10:47 AM
|
ae_maxm |
NEW_DATA_ELEMENT |
|
|
06/20/2016 10:47 AM
|
rand_num |
NEW_DATA_ELEMENT |
|
|
06/20/2016 10:47 AM
|
rand_num |
NEW_MAP_ELEMENT |
|
Added data element 'rand_num' to data structure 'adev01'. |
06/20/2016 10:47 AM
|
ae_intermit |
NEW_DATA_ELEMENT |
|
|
06/20/2016 10:47 AM
|
gender |
VALUE_RANGE, NOTES |
VALUE_RANGE: M;F; T
NOTES: M = Male; F = Female; T= Transgender |
VALUE_RANGE: M;F
NOTES: M = Male; F = Female |
05/25/2016 11:51 AM
|
gender |
DESCRIPTION |
DESCRIPTION: Gender |
DESCRIPTION: Sex of the subject |
05/25/2016 11:50 AM
|
scid_event_age1 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age2 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age3 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age4 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age5 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age6 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age7 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 PM
|
scid_event_age8 |
NEW_DATA_ELEMENT |
|
|
05/18/2016 16:53 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; 11=Lost to follow up; 12=Other; -9=unknown |
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 |
05/02/2016 10:53 AM
|
aef001 |
ELEMENT_SIZE |
ELEMENT_SIZE: 2 |
ELEMENT_SIZE: |
04/29/2016 11:34 AM
|
aef005 |
ELEMENT_SIZE |
ELEMENT_SIZE: 2 |
ELEMENT_SIZE: |
04/29/2016 11:34 AM
|
aef008 |
ELEMENT_SIZE |
ELEMENT_SIZE: 2 |
ELEMENT_SIZE: |
04/29/2016 11:34 AM
|
aesa21a1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe |
VALUE_RANGE: 0;1;2;3;8;9
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed |
04/13/2016 15:23 PM
|
aesa21b1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe |
VALUE_RANGE: 0;1;2;3;8;9
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed |
04/13/2016 15:23 PM
|
aesa21c1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe |
VALUE_RANGE: 0;1;2;3;8;9
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed |
04/13/2016 15:23 PM
|
aesa21d1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe |
VALUE_RANGE: 0;1;2;3;8;9
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed |
04/13/2016 15:23 PM
|
saps_ad10 |
NEW_MAP_ELEMENT |
|
Added data element 'saps_ad10' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7cda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7cda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7dda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7dda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7eda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7eda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7fda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7fda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7gda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7gda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7hda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7hda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7ida |
NEW_MAP_ELEMENT |
|
Added data element 'ae7ida' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7jda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7jda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7kda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7kda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7lda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7lda' to data structure 'adev01'. |
04/13/2016 15:21 PM
|
ae7ada |
NEW_MAP_ELEMENT |
|
Added data element 'ae7ada' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
ae7bda |
NEW_MAP_ELEMENT |
|
Added data element 'ae7bda' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21e1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21e1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21f1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21f1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21g1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21g1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21h1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21h1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21i1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21i1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21j1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21j1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21k1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21k1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
aesa21l1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21l1' to data structure 'adev01'. |
04/13/2016 15:20 PM
|
ae7ada |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7bda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7cda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7dda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7eda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7fda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7gda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7hda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7ida |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7jda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7kda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
ae7lda |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21e1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21f1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21g1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21h1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21i1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21j1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21k1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
aesa21l1 |
NEW_DATA_ELEMENT |
|
|
04/13/2016 15:20 PM
|
chartreview059 |
DESCRIPTION |
DESCRIPTION: Primary ED physician discharge diagnosis |
DESCRIPTION: Medical inpatient hospitalizations |
04/13/2016 14:25 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
03/18/2016 13:48 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
03/18/2016 13:44 PM
|
corther |
NEW_MAP_ELEMENT |
|
Added data element 'corther' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
excour |
NEW_MAP_ELEMENT |
|
Added data element 'excour' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
freq_increased |
NEW_MAP_ELEMENT |
|
Added data element 'freq_increased' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
rpttp |
NEW_MAP_ELEMENT |
|
Added data element 'rpttp' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
sev_increased |
NEW_MAP_ELEMENT |
|
Added data element 'sev_increased' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
withdrawn |
NEW_MAP_ELEMENT |
|
Added data element 'withdrawn' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
q13_pre |
NEW_MAP_ELEMENT |
|
Added data element 'q13_pre' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
corther |
NEW_DATA_ELEMENT |
|
|
03/18/2016 11:13 AM
|
dayae |
NEW_MAP_ELEMENT |
|
Added data element 'dayae' to data structure 'adev01'. |
03/18/2016 11:13 AM
|
excour |
NEW_DATA_ELEMENT |
|
|
03/18/2016 11:13 AM
|
sev_increased |
NEW_DATA_ELEMENT |
|
|
03/18/2016 11:13 AM
|
withdrawn |
NEW_DATA_ELEMENT |
|
|
03/18/2016 11:13 AM
|
freq_increased |
NEW_DATA_ELEMENT |
|
|
03/18/2016 11:13 AM
|
darsrz |
DESCRIPTION |
DESCRIPTION: |
DESCRIPTION: Days since randomization |
03/18/2016 11:12 AM
|
maxinten |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0 = Moderate 1 = Severe |
VALUE_RANGE: 0::2
NOTES: 0 = Moderate; 1 = Severe; 2=Mild |
03/18/2016 11:10 AM
|
intensity |
NEW_DATA_ELEMENT |
|
|
01/11/2016 16:09 PM
|
sefgass16 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
12/23/2015 12:02 PM
|
se_b12 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::4
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done |
VALUE_RANGE: 0::4; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown |
12/23/2015 11:47 AM
|
se_b16 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
12/23/2015 11:47 AM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
11/13/2015 15:15 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
11/13/2015 14:19 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
11/09/2015 11:13 AM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
11/09/2015 11:02 AM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
11/02/2015 13:17 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
11/02/2015 12:42 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
10/07/2015 14:37 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
10/07/2015 12:52 PM
|
saea19 |
VALUE_RANGE |
VALUE_RANGE: A;B;C;D: E; F; U |
VALUE_RANGE: A;B;C;D;E;F;U |
10/06/2015 18:04 PM
|
tx_code |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0=Olanzapine & Placebo; 1=Olanzapine & Sertraline |
VALUE_RANGE: 0::3
NOTES: 0=Olanzapine + Sertraline Placebo; 1=Olanzapine + Sertraline; 2=Olanzapine + Sertraline + Lithium Placebo; 3=Olanzapine + Sertraline + Lithium |
10/06/2015 18:02 PM
|
ci_enrolled |
NEW_MAP_ELEMENT |
|
Added data element 'ci_enrolled' to data structure 'adev01'. |
10/06/2015 16:08 PM
|
darsrz |
NEW_DATA_ELEMENT |
|
|
10/06/2015 16:08 PM
|
darsrz |
NEW_MAP_ELEMENT |
|
Added data element 'darsrz' to data structure 'adev01'. |
10/06/2015 16:08 PM
|
ae_serious_signific |
NEW_MAP_ELEMENT |
|
Added data element 'ae_serious_signific' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
dsabl |
NEW_MAP_ELEMENT |
|
Added data element 'dsabl' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
hsptl |
NEW_MAP_ELEMENT |
|
Added data element 'hsptl' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
lfthr |
NEW_MAP_ELEMENT |
|
Added data element 'lfthr' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
altillns |
NEW_MAP_ELEMENT |
|
Added data element 'altillns' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
altnone |
NEW_MAP_ELEMENT |
|
Added data element 'altnone' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
altothr |
NEW_MAP_ELEMENT |
|
Added data element 'altothr' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
conspec |
NEW_MAP_ELEMENT |
|
Added data element 'conspec' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
death |
NEW_MAP_ELEMENT |
|
Added data element 'death' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
defect |
NEW_MAP_ELEMENT |
|
Added data element 'defect' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
description_of_sae |
NEW_MAP_ELEMENT |
|
Added data element 'description_of_sae' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
inilspec |
NEW_MAP_ELEMENT |
|
Added data element 'inilspec' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
othspec |
NEW_MAP_ELEMENT |
|
Added data element 'othspec' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
stprspec |
NEW_MAP_ELEMENT |
|
Added data element 'stprspec' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
aespdtm |
NEW_MAP_ELEMENT |
|
Added data element 'aespdtm' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
altproc |
NEW_MAP_ELEMENT |
|
Added data element 'altproc' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
drugrsdt |
NEW_MAP_ELEMENT |
|
Added data element 'drugrsdt' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
ratrel |
NEW_MAP_ELEMENT |
|
Added data element 'ratrel' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
saea19 |
NEW_MAP_ELEMENT |
|
Added data element 'saea19' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
saedimtd |
NEW_MAP_ELEMENT |
|
Added data element 'saedimtd' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
saedinrd |
NEW_MAP_ELEMENT |
|
Added data element 'saedinrd' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
saedispd |
NEW_MAP_ELEMENT |
|
Added data element 'saedispd' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
saerapr |
NEW_MAP_ELEMENT |
|
Added data element 'saerapr' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
stdate |
NEW_MAP_ELEMENT |
|
Added data element 'stdate' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
aespdtm |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
aestdtm |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
aestdtm |
NEW_MAP_ELEMENT |
|
Added data element 'aestdtm' to data structure 'adev01'. |
09/30/2015 17:13 PM
|
altillns |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
altnone |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
altothr |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
altproc |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
conspec |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
drugrsdt |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
inilspec |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
othspec |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
ratrel |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
saedimtd |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
saedinrd |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
saedispd |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
saerapr |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
stprspec |
NEW_DATA_ELEMENT |
|
|
09/30/2015 17:13 PM
|
action |
VALUE_RANGE, NOTES |
VALUE_RANGE: A; B; C;D; E; F; G
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued |
VALUE_RANGE: A; B; C;D; E; F; G;U
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown |
09/30/2015 17:12 PM
|
saea19 |
VALUE_RANGE, NOTES |
VALUE_RANGE: A;B;C;D
NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequeale |
VALUE_RANGE: A;B;C;D: E; F; U
NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequelae;E=Not recovered; F=Recovering; U=Unknown |
09/30/2015 17:12 PM
|
days_baseline |
NEW_MAP_ELEMENT |
|
Added data element 'days_baseline' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
hosp |
NEW_MAP_ELEMENT |
|
Added data element 'hosp' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
rev_orthofracture |
NEW_MAP_ELEMENT |
|
Added data element 'rev_orthofracture' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
severityoffall |
NEW_MAP_ELEMENT |
|
Added data element 'severityoffall' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
typeoffall |
NEW_MAP_ELEMENT |
|
Added data element 'typeoffall' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
adverse_event_code |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
adverse_event_code |
NEW_MAP_ELEMENT |
|
Added data element 'adverse_event_code' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
agegroup |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
agegroup |
NEW_MAP_ELEMENT |
|
Added data element 'agegroup' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
recoverydays |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
recoverydays |
NEW_MAP_ELEMENT |
|
Added data element 'recoverydays' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
severityoffall |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
study_id |
NEW_MAP_ELEMENT |
|
Added data element 'study_id' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
tx_code |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
tx_code |
NEW_MAP_ELEMENT |
|
Added data element 'tx_code' to data structure 'adev01'. |
09/24/2015 14:33 PM
|
typeoffall |
NEW_DATA_ELEMENT |
|
|
09/24/2015 14:33 PM
|
study_id |
NOTES |
NOTES: |
NOTES: 46=Acute Phase; 47=Stabilization Phase |
09/24/2015 12:50 PM
|
ci_enrolled |
NOTES |
NOTES: |
NOTES: 0=No; 1=Yes |
09/15/2015 17:24 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
09/04/2015 16:23 PM
|
trtgroup |
NEW_MAP_ELEMENT |
|
Added data element 'trtgroup' to data structure 'adev01'. |
09/04/2015 16:14 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
09/04/2015 16:00 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/24/2015 16:03 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/24/2015 15:27 PM
|
visnum |
NEW_MAP_ELEMENT |
|
Added data element 'visnum' to data structure 'adev01'. |
08/24/2015 13:31 PM
|
trtgroup |
NEW_DATA_ELEMENT |
|
|
08/21/2015 10:22 AM
|
ae4t |
NEW_MAP_ELEMENT |
|
Added data element 'ae4t' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
days_visit1 |
NEW_MAP_ELEMENT |
|
Added data element 'days_visit1' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
intrt |
NEW_MAP_ELEMENT |
|
Added data element 'intrt' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
trtgrp_p |
NEW_MAP_ELEMENT |
|
Added data element 'trtgrp_p' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae1t |
NEW_MAP_ELEMENT |
|
Added data element 'ae1t' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae2t |
NEW_MAP_ELEMENT |
|
Added data element 'ae2t' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae3t |
NEW_MAP_ELEMENT |
|
Added data element 'ae3t' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae_14 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_14' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae_16 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_16' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae_20 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_20' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae_3 |
NEW_MAP_ELEMENT |
|
Added data element 'ae_3' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
pwc015 |
NEW_MAP_ELEMENT |
|
Added data element 'pwc015' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
aer016a |
NEW_MAP_ELEMENT |
|
Added data element 'aer016a' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sefcnss30 |
NEW_MAP_ELEMENT |
|
Added data element 'sefcnss30' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sefgens49 |
NEW_MAP_ELEMENT |
|
Added data element 'sefgens49' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sefoths61 |
NEW_MAP_ELEMENT |
|
Added data element 'sefoths61' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sft003 |
NEW_MAP_ELEMENT |
|
Added data element 'sft003' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sft006 |
NEW_MAP_ELEMENT |
|
Added data element 'sft006' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
sft015 |
NEW_MAP_ELEMENT |
|
Added data element 'sft015' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae1t |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae2t |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae3t |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae4t |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae_16 |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae_20 |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
ae_3 |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
safte50 |
NEW_MAP_ELEMENT |
|
Added data element 'safte50' to data structure 'adev01'. |
08/20/2015 10:40 AM
|
ae_14 |
NEW_DATA_ELEMENT |
|
|
08/20/2015 10:40 AM
|
days_visit1 |
NEW_DATA_ELEMENT |
|
|
08/19/2015 16:48 PM
|
intrt |
NEW_DATA_ELEMENT |
|
|
08/19/2015 16:48 PM
|
trtgrp_p |
NEW_DATA_ELEMENT |
|
|
08/19/2015 16:48 PM
|
stage |
VALUE_RANGE |
VALUE_RANGE: 0::5; 51::53; 67; -888; - 999 |
VALUE_RANGE: 0::5; 51::53; 67; -888; -999 |
08/18/2015 10:11 AM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
08/17/2015 16:02 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
08/17/2015 15:57 PM
|
otr_actn_02 |
NEW_MAP_ELEMENT |
|
Added data element 'otr_actn_02' to data structure 'adev01'. |
08/12/2015 13:40 PM
|
otr_actn_03 |
NEW_MAP_ELEMENT |
|
Added data element 'otr_actn_03' to data structure 'adev01'. |
08/12/2015 13:40 PM
|
otr_actn_01 |
NEW_DATA_ELEMENT |
|
|
08/12/2015 13:40 PM
|
otr_actn_01 |
NEW_MAP_ELEMENT |
|
Added data element 'otr_actn_01' to data structure 'adev01'. |
08/12/2015 13:40 PM
|
otr_actn_02 |
NEW_DATA_ELEMENT |
|
|
08/12/2015 13:40 PM
|
otr_actn_03 |
NEW_DATA_ELEMENT |
|
|
08/12/2015 13:40 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
07/30/2015 12:55 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
07/30/2015 12:48 PM
|
ham_a_q7 |
NEW_MAP_ELEMENT |
|
Added data element 'ham_a_q7' to data structure 'adev01'. |
07/30/2015 11:21 AM
|
gender |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
07/23/2015 11:32 AM
|
pwc016 |
NEW_MAP_ELEMENT |
|
Added data element 'pwc016' to data structure 'adev01'. |
07/22/2015 15:04 PM
|
se_b12 |
NEW_MAP_ELEMENT |
|
Added data element 'se_b12' to data structure 'adev01'. |
07/22/2015 15:04 PM
|
se_b16 |
NEW_MAP_ELEMENT |
|
Added data element 'se_b16' to data structure 'adev01'. |
07/22/2015 15:04 PM
|
sefgass16 |
NEW_MAP_ELEMENT |
|
Added data element 'sefgass16' to data structure 'adev01'. |
07/22/2015 15:04 PM
|
sefgass6 |
NEW_MAP_ELEMENT |
|
Added data element 'sefgass6' to data structure 'adev01'. |
07/22/2015 15:04 PM
|
ham_a_q7 |
NEW_DATA_ELEMENT |
|
|
07/16/2015 12:08 PM
|
sefgass6 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
VALUE_RANGE: 0::4; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done |
07/14/2015 18:17 PM
|
sefcnss30 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
VALUE_RANGE: 0::4; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done |
07/14/2015 18:16 PM
|
se_b16 |
NOTES |
NOTES: "0=Absent, 1=Mild, 2=Moderate, 3=Severe" |
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
07/14/2015 18:15 PM
|
se_b12 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: "0=Absent, 1=Mild, 2=Moderate, 3=Severe" |
VALUE_RANGE: 0::4
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done |
07/14/2015 18:15 PM
|
aesa20 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe |
VALUE_RANGE: 0::4
NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 4=not done |
07/14/2015 18:09 PM
|
aer016a |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3;-9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
VALUE_RANGE: 0::4;-9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done |
07/14/2015 18:08 PM
|
cbcl1_2_text |
ELEMENT_SIZE |
ELEMENT_SIZE: 62 |
ELEMENT_SIZE: 500 |
07/14/2015 13:40 PM
|
aeout |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::10; -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; -9=unknown |
VALUE_RANGE: 1::12; -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; 11=Lost to follow up; 12=Other; -9=unknown |
07/13/2015 15:12 PM
|
aeacn |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::3
NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily |
VALUE_RANGE: 1::5; 99
NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other |
07/13/2015 15:12 PM
|
session_id |
NEW_MAP_ELEMENT |
|
Added data element 'session_id' to data structure 'adev01'. |
07/13/2015 15:11 PM
|
demo_health_condsp |
NEW_DATA_ELEMENT |
|
|
06/26/2015 17:58 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
06/18/2015 10:25 AM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
06/18/2015 10:06 AM
|
sdatothr |
TYPE, ELEMENT_SIZE |
TYPE: Integer
ELEMENT_SIZE: |
TYPE: String
ELEMENT_SIZE: 60 |
06/16/2015 13:54 PM
|
othact1 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1
NOTES: 1 = Yes |
VALUE_RANGE: 1;0
NOTES: 1 = Yes; 0=No |
06/16/2015 11:33 AM
|
othact2 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1
NOTES: 1 = Yes |
VALUE_RANGE: 1;0
NOTES: 1 = Yes; 0=No |
06/16/2015 11:33 AM
|
othact3 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1
NOTES: 1 = Yes |
VALUE_RANGE: 1;0
NOTES: 1 = Yes; 0=No |
06/16/2015 11:33 AM
|
othact4 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1
NOTES: 1 = Yes |
VALUE_RANGE: 1;0
NOTES: 1 = Yes; 0=No |
06/16/2015 11:33 AM
|
aefther |
NOTES |
NOTES: 0 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator) |
NOTES: 0 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator) |
06/11/2015 16:29 PM
|
aer016a |
VALUE_RANGE |
VALUE_RANGE: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
VALUE_RANGE: 0::3;-9 |
06/08/2015 10:50 AM
|
dayae |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:56 PM
|
sdrugact |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::11
NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose
|
VALUE_RANGE: 1::12
NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose; 12= other
|
06/05/2015 16:36 PM
|
aecat |
NEW_MAP_ELEMENT |
|
Added data element 'aecat' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
dayresolved |
NEW_MAP_ELEMENT |
|
Added data element 'dayresolved' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
fdacrit |
NEW_MAP_ELEMENT |
|
Added data element 'fdacrit' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
sdatothr |
NEW_MAP_ELEMENT |
|
Added data element 'sdatothr' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
status |
NEW_MAP_ELEMENT |
|
Added data element 'status' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
withdrug |
NEW_MAP_ELEMENT |
|
Added data element 'withdrug' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
aecat |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
aefreqnc |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
aefreqnc |
NEW_MAP_ELEMENT |
|
Added data element 'aefreqnc' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
aefther |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
aefther |
NEW_MAP_ELEMENT |
|
Added data element 'aefther' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
dayonset |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
dayonset |
NEW_MAP_ELEMENT |
|
Added data element 'dayonset' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
dayresolved |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
fdacrit |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
onsetstg |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
onsetstg |
NEW_MAP_ELEMENT |
|
Added data element 'onsetstg' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
reportpd |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
reportpd |
NEW_MAP_ELEMENT |
|
Added data element 'reportpd' to data structure 'adev01'. |
06/05/2015 16:34 PM
|
sdatothr |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
withdrug |
NEW_DATA_ELEMENT |
|
|
06/05/2015 16:34 PM
|
aer016a |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
06/05/2015 15:06 PM
|
sefcnss30 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
06/05/2015 15:05 PM
|
sefgass6 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::3
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe |
VALUE_RANGE: 0::3; -9
NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown |
06/05/2015 15:04 PM
|
sft003 |
VALUE_RANGE |
VALUE_RANGE: |
VALUE_RANGE: 0::3; -9 |
06/05/2015 11:13 AM
|
sft006 |
VALUE_RANGE |
VALUE_RANGE: |
VALUE_RANGE: 0::3; -9 |
06/05/2015 11:13 AM
|
sft015 |
VALUE_RANGE |
VALUE_RANGE: |
VALUE_RANGE: 0::3; -9 |
06/05/2015 11:13 AM
|
sft003 |
DESCRIPTION, NOTES |
DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
NOTES: |
DESCRIPTION: Sedation/drowsiness
NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown |
06/04/2015 17:31 PM
|
sft006 |
DESCRIPTION, NOTES |
DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
NOTES: |
DESCRIPTION: Malaise
NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown |
06/04/2015 17:31 PM
|
sft015 |
DESCRIPTION, NOTES |
DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown
NOTES: |
DESCRIPTION: Dizziness/faintness
NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown |
06/04/2015 17:31 PM
|
sft003 |
NEW_DATA_ELEMENT |
|
|
06/04/2015 17:22 PM
|
sft006 |
NEW_DATA_ELEMENT |
|
|
06/04/2015 17:22 PM
|
sft015 |
NEW_DATA_ELEMENT |
|
|
06/04/2015 17:22 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
06/04/2015 16:35 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
06/04/2015 16:23 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
06/04/2015 15:13 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
06/04/2015 14:26 PM
|
aef001 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::99
NOTES: |
VALUE_RANGE: 1::99; -9
NOTES: -9=unknown |
06/03/2015 16:49 PM
|
aef008 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::6
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); |
VALUE_RANGE: 1::6; -9
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown |
06/03/2015 16:49 PM
|
aeout |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::10
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 |
VALUE_RANGE: 1::10; -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; -9=unknown |
06/03/2015 16:49 PM
|
aeser |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0 = No; 1 = Yes |
VALUE_RANGE: 0;1; -9
NOTES: 0 = No; 1 = Yes; -9=unknown |
06/03/2015 16:49 PM
|
aeexp |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: 0 = No; 1 = Yes |
VALUE_RANGE: 0;1; -9
NOTES: 0 = No; 1 = Yes; -9 =unknown |
06/03/2015 16:47 PM
|
aesev |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::4
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening |
VALUE_RANGE: 1::4; -9
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknown |
06/03/2015 16:45 PM
|
lab020 |
NEW_MAP_ELEMENT |
|
Added data element 'lab020' to data structure 'adev01'. |
06/03/2015 16:44 PM
|
action |
VALUE_RANGE, NOTES |
VALUE_RANGE: A; B; C;D
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable |
VALUE_RANGE: A; B; C;D; E; F; G
NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued |
06/03/2015 16:33 PM
|
interview_date |
DESCRIPTION |
DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY |
DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY |
06/02/2015 17:40 PM
|
interview_date |
DESCRIPTION |
DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed |
DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY |
06/02/2015 17:40 PM
|
e3_day |
NEW_MAP_ELEMENT |
|
Added data element 'e3_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
end_dy |
NEW_MAP_ELEMENT |
|
Added data element 'end_dy' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
eoc_day |
NEW_MAP_ELEMENT |
|
Added data element 'eoc_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
start_dy |
NEW_MAP_ELEMENT |
|
Added data element 'start_dy' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
b1_day |
NEW_MAP_ELEMENT |
|
Added data element 'b1_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
b2_day |
NEW_MAP_ELEMENT |
|
Added data element 'b2_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
b3_day |
NEW_MAP_ELEMENT |
|
Added data element 'b3_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
boc_day |
NEW_MAP_ELEMENT |
|
Added data element 'boc_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
e1_day |
NEW_MAP_ELEMENT |
|
Added data element 'e1_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
e2_day |
NEW_MAP_ELEMENT |
|
Added data element 'e2_day' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp10 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp10' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp11 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp11' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp12 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp12' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp13 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp13' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp14 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp14' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp15 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp15' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp9 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp9' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp1 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp1' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp2 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp2' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp3 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp3' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp4 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp4' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp5 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp5' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp6 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp6' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp7 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp7' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
socgrp8 |
NEW_MAP_ELEMENT |
|
Added data element 'socgrp8' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
te1 |
NEW_MAP_ELEMENT |
|
Added data element 'te1' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
te2 |
NEW_MAP_ELEMENT |
|
Added data element 'te2' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
te3 |
NEW_MAP_ELEMENT |
|
Added data element 'te3' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
tebase |
NEW_MAP_ELEMENT |
|
Added data element 'tebase' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
teoc |
NEW_MAP_ELEMENT |
|
Added data element 'teoc' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
phase_ct |
NEW_MAP_ELEMENT |
|
Added data element 'phase_ct' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
prf_term |
NEW_MAP_ELEMENT |
|
Added data element 'prf_term' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
reportid |
NEW_MAP_ELEMENT |
|
Added data element 'reportid' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
soc |
NEW_MAP_ELEMENT |
|
Added data element 'soc' to data structure 'adev01'. |
06/01/2015 16:49 PM
|
action |
NEW_MAP_ELEMENT |
|
Added data element 'action' to data structure 'adev01'. |
06/01/2015 16:48 PM
|
end_dy |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
sae |
NEW_MAP_ELEMENT |
|
Added data element 'sae' to data structure 'adev01'. |
06/01/2015 16:48 PM
|
socgrp1 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp10 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp11 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp12 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp13 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp14 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp15 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp2 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp3 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp4 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp5 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp6 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp7 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp8 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
socgrp9 |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
start_dy |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
tebase |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
teoc |
NEW_DATA_ELEMENT |
|
|
06/01/2015 16:48 PM
|
interview_age |
VALUE_RANGE |
VALUE_RANGE: 0 :: 1200 |
VALUE_RANGE: 0 :: 1260 |
06/01/2015 14:16 PM
|
prf_term |
ELEMENT_SIZE |
ELEMENT_SIZE: 50 |
ELEMENT_SIZE: 100 |
06/01/2015 13:22 PM
|
boc_day |
NEW_DATA_ELEMENT |
|
|
05/29/2015 14:51 PM
|
eoc_day |
NEW_DATA_ELEMENT |
|
|
05/29/2015 14:51 PM
|
aestatuschange_1 |
NOTES |
NOTES: 73=No; 74=Yes, Ideation to Attempt; 75=Yes, Ideation to Completed Suicide; 76=Yes, attempt to Completed Suicide; 77=Not Applicable to this AE Type; -888=Not Applicable; -999=Missing; |
NOTES: 73=No; 74=Yes, Ideation to Attempt; 75=Yes, Ideation to Completed Suicide; 76=Yes, attempt to Completed Suicide; 77=Not Applicable to this AE Type; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
callcenterdatasource_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
crisiscenterdatasource_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
emnetaetype_1 |
NOTES |
NOTES: 39=NSSI; 40=Suicide Attempt; 41=Suicide Crisis; 42=Death Clearly not Intentional; 43=Death Unsure if Intentional; 44=Death Probably Intentional; 45=Death Clearly Intentional; 46=Hospitalization; 47=ED; 48=Other Distress Durring Assessment; 65=Other ED visit no documentation available; 66=Other Hospitalization no documentation available; 72=Boys Town Event; 78=Other; -888=Not Applicable; -999=Missing; |
NOTES: 39=NSSI; 40=Suicide Attempt; 41=Suicide Crisis; 42=Death Clearly not Intentional; 43=Death Unsure if Intentional; 44=Death Probably Intentional; 45=Death Clearly Intentional; 46=Hospitalization; 47=ED; 48=Other Distress Durring Assessment; 65=Other ED visit no documentation available; 66=Other Hospitalization no documentation available; 72=Boys Town Event; 78=Other; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
emnetisdead_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
emnetother_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationdeath_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationhospdetox_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationhosplmed_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationhosppsych_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationnohosp_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationoth_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
noselfharmideationunknown_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideation_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationcrisiscall_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationcrisisedvis_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationdeath_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationhospdetox_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationhospmed_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationhosppsych_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationnohosp_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationother_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationpolice_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationtransfer_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
selfharmideationunknown_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
sitedatasource_1 |
NOTES |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
source_1 |
NOTES |
NOTES: 33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing; |
NOTES: 33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
studyrelation_1 |
NOTES |
NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; |
NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
wk6c11a |
NOTES |
NOTES: 1=Yes; 2=No; 98=Refused; -888=Not Applicable; -999=Missing; |
NOTES: 1=Yes; 2=No; 98=Refused; -888=Not Applicable; -999=Missing; |
05/29/2015 13:35 PM
|
rpttp |
NOTES |
NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; |
NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; |
05/29/2015 13:34 PM
|
comments_misc |
DESCRIPTION |
DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data |
DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data |
05/29/2015 13:29 PM
|
phase_ct |
VALUE_RANGE |
VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase |
VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1 |
05/28/2015 18:32 PM
|
visnum |
NEW_DATA_ELEMENT |
|
|
05/28/2015 12:48 PM
|
phase_ct |
VALUE_RANGE |
VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B |
VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase |
05/28/2015 12:11 PM
|
site |
ELEMENT_SIZE |
ELEMENT_SIZE: 20 |
ELEMENT_SIZE: 100 |
05/26/2015 11:15 AM
|
rpttp |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1;2
NOTES: "1=Initial, 2=Follow-up" |
VALUE_RANGE: 1::4
NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; |
05/21/2015 15:11 PM
|
week |
NOTES |
NOTES: |
NOTES: 99=week 10-week 14 |
05/19/2015 18:30 PM
|
cbcl1_2_text |
NEW_DATA_ELEMENT |
|
|
05/04/2015 15:54 PM
|
safte50 |
NEW_DATA_ELEMENT |
|
|
04/29/2015 15:42 PM
|
ae_serious_signific |
NEW_DATA_ELEMENT |
|
|
04/27/2015 17:37 PM
|
description_of_sae |
NEW_DATA_ELEMENT |
|
|
04/27/2015 17:37 PM
|
interview_age |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
04/23/2015 15:11 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
04/23/2015 15:11 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
04/23/2015 14:40 PM
|
sdrugact |
VALUE_RANGE |
VALUE_RANGE: 1::9 |
VALUE_RANGE: 1::11 |
04/23/2015 11:51 AM
|
aeconmed |
NEW_MAP_ELEMENT |
|
Added data element 'aeconmed' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
aeinit |
NEW_MAP_ELEMENT |
|
Added data element 'aeinit' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
aerisk |
NEW_MAP_ELEMENT |
|
Added data element 'aerisk' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
irbrprt |
NEW_MAP_ELEMENT |
|
Added data element 'irbrprt' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
irbrptdt |
NEW_MAP_ELEMENT |
|
Added data element 'irbrptdt' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
sibre |
NEW_MAP_ELEMENT |
|
Added data element 'sibre' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
sqlatxt |
NEW_MAP_ELEMENT |
|
Added data element 'sqlatxt' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
aechng |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aechng |
NEW_MAP_ELEMENT |
|
Added data element 'aechng' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
aeconmed |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aeinit |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aerisk |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aeterm |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aeterm |
NEW_MAP_ELEMENT |
|
Added data element 'aeterm' to data structure 'adev01'. |
04/23/2015 11:31 AM
|
irbrprt |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
irbrptdt |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
sibre |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
sqlatxt |
NEW_DATA_ELEMENT |
|
|
04/23/2015 11:31 AM
|
aeonstm |
NEW_DATA_ELEMENT |
|
|
04/22/2015 18:12 PM
|
aeonstm |
NEW_MAP_ELEMENT |
|
Added data element 'aeonstm' to data structure 'adev01'. |
04/22/2015 18:12 PM
|
aef002 |
ELEMENT_SIZE |
ELEMENT_SIZE: 50 |
ELEMENT_SIZE: 250 |
04/22/2015 17:07 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
04/17/2015 15:02 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
04/17/2015 13:06 PM
|
aesa5 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1;2;3
NOTES: Absent=0; Mild=1; Moderate=2; Severe=3 |
VALUE_RANGE: 0::4
NOTES: Absent=0; Mild=1; Moderate=2; Severe=3; 4=N/A |
04/15/2015 15:22 PM
|
aeact3 |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aeact3 |
NEW_MAP_ELEMENT |
|
Added data element 'aeact3' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aeany |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aeany |
NEW_MAP_ELEMENT |
|
Added data element 'aeany' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aedurhr |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aedurhr |
NEW_MAP_ELEMENT |
|
Added data element 'aedurhr' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aedurmin |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aedurmin |
NEW_MAP_ELEMENT |
|
Added data element 'aedurmin' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aeonsdt |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aeonsdt |
NEW_MAP_ELEMENT |
|
Added data element 'aeonsdt' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aerestm |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aerestm |
NEW_MAP_ELEMENT |
|
Added data element 'aerestm' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
aetot |
NEW_DATA_ELEMENT |
|
|
04/13/2015 15:27 PM
|
aetot |
NEW_MAP_ELEMENT |
|
Added data element 'aetot' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
pmmednum |
NEW_MAP_ELEMENT |
|
Added data element 'pmmednum' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
study |
NEW_MAP_ELEMENT |
|
Added data element 'study' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
subtrial_name |
NEW_MAP_ELEMENT |
|
Added data element 'subtrial_name' to data structure 'adev01'. |
04/13/2015 15:27 PM
|
sdrugact |
NOTES |
NOTES: 1 = Dose increased; 2 = Dose reduced3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued |
NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose
|
04/13/2015 14:48 PM
|
aesev |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::3
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe |
VALUE_RANGE: 1::4
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening |
04/13/2015 14:42 PM
|
aeout |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::5
NOTES: 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown |
VALUE_RANGE: 1::10
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 |
04/13/2015 14:37 PM
|
aef005 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::4;9
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable; |
VALUE_RANGE: 1::7;9
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable; |
04/13/2015 14:08 PM
|
pmmednum |
NEW_DATA_ELEMENT |
|
|
04/13/2015 12:45 PM
|
subtrial_name |
NEW_DATA_ELEMENT |
|
|
04/13/2015 11:51 AM
|
study |
NOTES |
NOTES: CPEA or STAART Study |
NOTES: |
04/13/2015 11:31 AM
|
aesa12f |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa12f |
NEW_MAP_ELEMENT |
|
Added data element 'aesa12f' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa16 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa16 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa16' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa18 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa18 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa18' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa19 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa19 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa19' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa20 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa20 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa20' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa21a1 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa21a1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21a1' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa21b1 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa21b1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21b1' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa21c1 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa21c1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21c1' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa21d |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa21d |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21d' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa21d1 |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa21d1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa21d1' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa7f |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa7f |
NEW_MAP_ELEMENT |
|
Added data element 'aesa7f' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa8f |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa8f |
NEW_MAP_ELEMENT |
|
Added data element 'aesa8f' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
aesa9f |
NEW_DATA_ELEMENT |
|
|
04/10/2015 12:42 PM
|
aesa9f |
NEW_MAP_ELEMENT |
|
Added data element 'aesa9f' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
daysrz |
NEW_MAP_ELEMENT |
|
Added data element 'daysrz' to data structure 'adev01'. |
04/10/2015 12:42 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
04/07/2015 15:50 PM
|
interview_date |
REQUIRED |
REQUIRED: Required |
REQUIRED: Recommended |
04/07/2015 15:32 PM
|
aesa14 |
TYPE |
TYPE: String |
TYPE: Float |
04/06/2015 08:09 AM
|
aes3svrt |
VALUE_RANGE, NOTES |
VALUE_RANGE: 1::3
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe |
VALUE_RANGE: 0::3
NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 0=Absent |
04/03/2015 16:54 PM
|
aesa14 |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0;1
NOTES: No=0; Yes=1; |
VALUE_RANGE:
NOTES: |
04/03/2015 16:52 PM
|
saea19 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 15:56 PM
|
aesa10 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa10' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa11 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa11' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa12 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa12' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa13 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa13' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa14 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa14' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa15 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa15' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa7 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa7' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa8 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa8' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa9 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa9' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
version_form |
NEW_MAP_ELEMENT |
|
Added data element 'version_form' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa1 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa1 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa1' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa10 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa11 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa12 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa13 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa14 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa15 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa4 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa4 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa4' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa5 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa5 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa5' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa6 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa6 |
NEW_MAP_ELEMENT |
|
Added data element 'aesa6' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
aesa7 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa8 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
aesa9 |
NEW_DATA_ELEMENT |
|
|
04/02/2015 13:51 PM
|
constisv |
NEW_MAP_ELEMENT |
|
Added data element 'constisv' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
drymthsv |
NEW_MAP_ELEMENT |
|
Added data element 'drymthsv' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
fseqno |
NEW_MAP_ELEMENT |
|
Added data element 'fseqno' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
visday |
NEW_MAP_ELEMENT |
|
Added data element 'visday' to data structure 'adev01'. |
04/02/2015 13:51 PM
|
pwc015 |
NEW_DATA_ELEMENT |
|
|
04/01/2015 18:28 PM
|
pwc016 |
NEW_DATA_ELEMENT |
|
|
04/01/2015 18:28 PM
|
aer016a |
NEW_DATA_ELEMENT |
|
|
04/01/2015 18:11 PM
|
lab020 |
NEW_DATA_ELEMENT |
|
|
04/01/2015 17:02 PM
|
fseqno |
NEW_DATA_ELEMENT |
|
|
04/01/2015 12:43 PM
|
interview_date |
REQUIRED |
REQUIRED: Recommended |
REQUIRED: Required |
03/26/2015 12:22 PM
|
sefgens49 |
NEW_DATA_ELEMENT |
|
|
03/24/2015 13:56 PM
|
sefcnss30 |
NEW_DATA_ELEMENT |
|
|
03/24/2015 13:56 PM
|
sefgass16 |
NEW_DATA_ELEMENT |
|
|
03/24/2015 13:56 PM
|
sefgass6 |
NEW_DATA_ELEMENT |
|
|
03/24/2015 13:56 PM
|
sefoths61 |
NEW_DATA_ELEMENT |
|
|
03/24/2015 13:56 PM
|
wk6c11a |
NEW_DATA_ELEMENT |
|
|
03/10/2015 18:33 PM
|
selfharmideation_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideation_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationpolice_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationpolice_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationtransfer_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationtransfer_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationunknown_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationunknown_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
severity_1 |
NEW_MAP_ELEMENT |
|
Added data element 'severity_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
sitedatasource_1 |
NEW_MAP_ELEMENT |
|
Added data element 'sitedatasource_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
source_1 |
NEW_MAP_ELEMENT |
|
Added data element 'source_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
studyrelation_1 |
NEW_MAP_ELEMENT |
|
Added data element 'studyrelation_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
updated_date_1 |
NEW_MAP_ELEMENT |
|
Added data element 'updated_date_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
emnetother_1 |
NEW_MAP_ELEMENT |
|
Added data element 'emnetother_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationdeath_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationdeath_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationhospdetox_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationhospdetox_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationhosplmed_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationhosplmed_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationhosppsych_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationhosppsych_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationnohosp_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationnohosp_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationoth_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationoth_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationothval_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationothval_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationunknown_1 |
NEW_MAP_ELEMENT |
|
Added data element 'noselfharmideationunknown_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
saenumber_1 |
NEW_MAP_ELEMENT |
|
Added data element 'saenumber_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationcrisiscall_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationcrisiscall_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationcrisisedvis_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationcrisisedvis_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationdeath_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationdeath_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationhospdetox_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationhospdetox_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationhospmed_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationhospmed_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationhosppsych_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationhosppsych_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationnohosp_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationnohosp_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationother_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationother_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
selfharmideationothervalue_1 |
NEW_MAP_ELEMENT |
|
Added data element 'selfharmideationothervalue_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
aestatuschange_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
aestatuschange_1 |
NEW_MAP_ELEMENT |
|
Added data element 'aestatuschange_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
callcenterdatasource_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
callcenterdatasource_1 |
NEW_MAP_ELEMENT |
|
Added data element 'callcenterdatasource_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
completed |
NEW_MAP_ELEMENT |
|
Added data element 'completed' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
crisiscenterdatasource_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
crisiscenterdatasource_1 |
NEW_MAP_ELEMENT |
|
Added data element 'crisiscenterdatasource_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
deathreportnumber_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
deathreportnumber_1 |
NEW_MAP_ELEMENT |
|
Added data element 'deathreportnumber_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
discoveryperiod_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
discoveryperiod_1 |
NEW_MAP_ELEMENT |
|
Added data element 'discoveryperiod_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
emnetaetype_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
emnetaetype_1 |
NEW_MAP_ELEMENT |
|
Added data element 'emnetaetype_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
emnetisdead_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
emnetisdead_1 |
NEW_MAP_ELEMENT |
|
Added data element 'emnetisdead_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
emnetother_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
emnetothervalue_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
emnetothervalue_1 |
NEW_MAP_ELEMENT |
|
Added data element 'emnetothervalue_1' to data structure 'adev01'. |
03/10/2015 15:47 PM
|
noselfharmideationdeath_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationhospdetox_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationhosplmed_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationhosppsych_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationnohosp_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationoth_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationothval_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
noselfharmideationunknown_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
saenumber_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideation_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationcrisiscall_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationcrisisedvis_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationdeath_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationhospdetox_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationhospmed_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationhosppsych_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationnohosp_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationother_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationothervalue_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationpolice_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationtransfer_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
selfharmideationunknown_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
sitedatasource_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
source_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
studyrelation_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
updated_date_1 |
NEW_DATA_ELEMENT |
|
|
03/10/2015 15:47 PM
|
stage |
VALUE_RANGE, NOTES |
VALUE_RANGE: 0::5
NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD) |
VALUE_RANGE: 0::5; 51::53; 67; -888; - 999
NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
|
03/10/2015 14:39 PM
|
hand_date |
DESCRIPTION |
DESCRIPTION: Date of Exam |
DESCRIPTION: reported date |
03/10/2015 14:35 PM
|
ae |
NOTES |
NOTES: Character text of 18 AEs/side effects that were systematically queried at each visit |
NOTES: |
03/10/2015 14:30 PM
|
chartreview059 |
NEW_DATA_ELEMENT |
|
|
03/03/2015 18:30 PM
|
sae_38 |
NEW_DATA_ELEMENT |
|
|
02/27/2015 15:02 PM
|
session_id |
DESCRIPTION |
DESCRIPTION: session ID |
DESCRIPTION: session ID/screening ID |
02/24/2015 11:04 AM
|
completed |
NEW_DATA_ELEMENT |
|
|
02/13/2015 11:34 AM
|
aef001 |
NOTES |
NOTES:
|
NOTES: |
01/13/2015 17:44 PM
|
aef005 |
NOTES |
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable;
|
NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable; |
01/13/2015 17:44 PM
|
aef008 |
NOTES |
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify);
|
NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); |
01/13/2015 17:44 PM
|
sdrugact |
NOTES |
NOTES: 1 = Dose increased; 2 = Dose reduced
3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded
6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued |
NOTES: 1 = Dose increased; 2 = Dose reduced3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued |
01/13/2015 17:44 PM
|
aesuicid |
DESCRIPTION |
DESCRIPTION: TADS Rating (not based on Columbia Coding):
Adverse Event was a suicide related event |
DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was a suicide related event |
01/13/2015 17:38 PM
|
leastsev |
DESCRIPTION |
DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.
Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.
Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
01/13/2015 17:38 PM
|
mostsev |
DESCRIPTION |
DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.
Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.
Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 |
01/13/2015 17:38 PM
|
othharm |
DESCRIPTION |
DESCRIPTION: TADS Rating (not based on Columbia Coding):
Adverse Event was classified as harm to others |
DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to others |
01/13/2015 17:38 PM
|
selfharm |
DESCRIPTION |
DESCRIPTION: TADS Rating (not based on Columbia Coding):
Adverse Event was classified as harm to self |
DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to self |
01/13/2015 17:38 PM
|
phase_ct |
DESCRIPTION |
DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase.
|
DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
01/13/2015 17:38 PM
|
src_subject_id |
DESCRIPTION |
DESCRIPTION: The site or study's subject identification |
DESCRIPTION: Subject ID how it's defined in lab/project |
01/12/2015 18:22 PM
|
med_nm |
NEW_DATA_ELEMENT |
|
|
01/07/2015 17:34 PM
|
version_form |
NEW_DATA_ELEMENT |
|
|
01/05/2015 16:36 PM
|
saps_ad10 |
NEW_DATA_ELEMENT |
|
|
01/05/2015 11:30 AM
|
week |
DESCRIPTION |
DESCRIPTION: Week in level |
DESCRIPTION: Week in level/study |
01/05/2015 11:19 AM
|
aerest0 |
TYPE |
TYPE: Integer |
TYPE: Float |
01/02/2015 14:41 PM
|
aestrt0 |
TYPE |
TYPE: Integer |
TYPE: Float |
01/02/2015 13:37 PM
|
constisv |
NEW_DATA_ELEMENT |
|
|
12/15/2014 16:38 PM
|
drymthsv |
NEW_DATA_ELEMENT |
|
|
12/15/2014 16:38 PM
|
sae |
NEW_DATA_ELEMENT |
|
|
12/10/2014 15:04 PM
|
mtype |
NEW_DATA_ELEMENT |
|
|
12/10/2014 14:32 PM
|
crcid |
DESCRIPTION |
DESCRIPTION: CRC ID |
DESCRIPTION: CRC ID/ROA ID |
12/09/2014 16:17 PM
|
study_id |
DESCRIPTION |
DESCRIPTION: Study ID number (assigned by NIMH) |
DESCRIPTION: Study ID number |
12/01/2014 12:48 PM
|
gender |
VALUE_RANGE, NOTES |
VALUE_RANGE: M;F
NOTES: M = Male; F = Female |
VALUE_RANGE: M;F; T
NOTES: M = Male; F = Female; T= Transgender |
12/01/2014 12:34 PM
|
comments_misc |
NEW_MAP_ELEMENT |
|
Added data element 'comments_misc' to data structure 'adev01'. |
10/20/2014 18:08 PM
|
comments_misc |
NEW_MAP_ELEMENT |
|
Added data element 'comments_misc' to data structure 'adev01'. |
10/20/2014 17:43 PM
|
comments_misc |
NEW_MAP_ELEMENT |
|
Added data element 'comments_misc' to data structure 'adev01'. |
02/25/2013 13:43 PM
|