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subjectkey |
GUID |
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Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
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src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
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CATIEID |
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interview_age |
Integer |
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Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
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Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
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interview_date |
Date |
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Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
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sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
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M = Male; F = Female; O=Other; NR = Not reported
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gender |
Query
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visitid |
Integer |
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Recommended |
MetaTrial Visit ID |
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System variable: unique code for each type of visit -use to merge files
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Query
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visit |
String |
60
|
Recommended |
Visit name |
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Query
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truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
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Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
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Query
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phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
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Query
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visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
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Query
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medad01 |
String |
10
|
Recommended |
What Phase was the patient in at the beginning |
1 or 1A; 1B; 2; 3; 4
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4=Open-Choice
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madh01 |
Query
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medad03 |
Float |
|
Recommended |
Proportion of capsules taken |
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A calculation done by the site of the proportion of prescribed capsules since the previous visit that were taken, based on pill count in the returned bottle. (This is a pill count estimate of compliance since the previous visit, and requires the patient to return the bottle) This field is only applicable to double-blind treatments (Phase 1/1a, Phase 2 except for Clozapine)
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Query
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medad06 |
Integer |
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Recommended |
Number of capsules prescribed per day |
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Prescribed dose since the previous visit. Patients could be prescribed between 1 and 4 double-blind capsules per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
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Query
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medad07 |
Integer |
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Recommended |
For Phase 2 open-label Clozapine, day |
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This field is only applicable for Phase 2 visits for patients on Clozapine. Prescribed dose since the previous visit (mg).
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Query
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msa04 |
Integer |
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Recommended |
has patient taken medication using dosage frequency by QTONE? |
0;1
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0=No; 1=Yes; Indicates if patients were instructed to take medication using the randomized dosing regimen, which is either QD - once per day or BID - twice per day. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
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Query
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msa04b |
Integer |
|
Recommended |
if no, the patient is taking the study medication |
1;2
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1= QD; 2= BID. This field is only applicable to double-blind treatment visits (Phase 1/1a, Phase 2 except for Clozapine)
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Query
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medad08 |
Integer |
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Recommended |
Medication 1 |
1::8
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
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Query
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medad10 |
Float |
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Recommended |
Prescribed dose since last visit |
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This field is only applicable to Phase 3 open-label visits
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Query
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medad11 |
Integer |
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Recommended |
Medication 2 |
1::8
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone;5= Perphenazine; 6=Clozapine; 7=Fluephenazine-D; 8=Aripiprazole
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Query
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medad13 |
Float |
|
Recommended |
Prescribed dose since last visit |
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This field is only applicable to Phase 3 open-label visits
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Query
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medad14 |
Integer |
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Recommended |
Clinical Global Judgment of Medication A |
1::4
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1=Always/Almost always [76-100% of the time]; 2=Usually [51-75% of the time]; 3=Sometimes [26-50% of the time]; 4=Never/Almost never [0-25% of the time]
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Query
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capsules |
Float |
|
Recommended |
Number of Capsules Prescribed/Day Since Last Visit |
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Number of capsules prescribed/day since the last visit=MEDAD06
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Query
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dose1 |
Float |
|
Recommended |
Prescribed Daily Dose in P1 (mg) |
|
# of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; PER: 8 mg; ZIP: 40 mg. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
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Query
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dose2 |
Float |
|
Recommended |
Prescribed Daily Dose in P2 (mg) |
|
# of capsules prescribed per day since the last visit multiplied by the capsule strength of treatment. Capsule strength is as follows: OLZ: 7.5 mg; QUET: 200 mg; RISP: 1.5 mg; ZIP: 40 mg. CLOZ: as reported in variable MEDAD07. Note: This is the dose in mg. This field does not contain the actual treatment assignment. Treatment assignments are not contained in this file - see file KEYVARS.
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Query
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dose3 |
Float |
|
Recommended |
Prescribed Daily Dose in P3 (mg) |
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As reported in variables MEDAD10 (first Phase 3 treatment) and MEDAD13 (second Phase 3 treatment). Missing if patient was receiving Dual treatment.
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Query
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presreg1 |
Integer |
|
Recommended |
P1 Prescribed Dosing Regimen |
1;2
|
1= Once a Day (BID); 2= Twice a Day (QD). This is usually equal to the randomized dosing regimen in Phase 1/1a (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
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Query
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presreg2 |
Integer |
|
Recommended |
P2 Prescribed Dosing Regimen |
1::3
|
1= Once a Day (BID); 2= Twice a Day (QD); 3=none (for clozapine). This is usually equal to the randomized dosing regimen in Phase 2 (see file KEYVARS for randomized dosing regimen variable), but if a patient was ever switched to a different regimen, (per MSA04 and MSA04B), then this takes the value of the regimen the patient was switched to. Value is stored on the first record per patient
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Query
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avgcaps1 |
Float |
|
Recommended |
Average number of capsules prescribed/day across phase 1/1A (mg) |
|
Value is stored on the first record per patient
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Query
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avgdose1 |
Float |
|
Recommended |
Average prescribed daily dose across phase 1/1a (mg) |
|
Value is stored on the first record per patient
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|
Query
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moddose1 |
Float |
|
Recommended |
Modal prescribed daily dose across phase 1/1a (mg) |
|
Value is stored on the first record per patient
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Query
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catcaps1 |
Integer |
|
Recommended |
Average Number of Capsiles Prescribed Across P1 (Cat) |
1::4
|
categorized version of AVGCAPS1 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules. Value is stored on the first record per patient
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Query
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avgcaps2 |
Float |
|
Recommended |
Average Number of Capsiles Prescribed Across P2 |
|
Average number of capsules prescribed/day across phase 2. Value is stored on the first record per patient
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Query
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avgdose2 |
Float |
|
Recommended |
Average Prescribed Dose Across P2 (mg) |
|
Average prescribed daily dose across phase 2 Value is stored on the first record per patient
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Query
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moddose2 |
Float |
|
Recommended |
Modal Prescribed Dose Across P2 (mg) |
|
Modal prescribed daily dose across phase 2 Value is stored on the first record per patient
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Query
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catcaps2 |
Integer |
|
Recommended |
Average Number of Capsiles Prescribed Across P2 (Cat) |
1::5
|
categorized version of AVGCAPS2 1= 1 capsule; 2= 2 capsules; 3= 3 capsules; 4= 4 capsules; 5= 5 capsules. Value is stored on the first record per patient
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Query
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avgdose3 |
Float |
|
Recommended |
Average Prescribed Dose Across P3(mg) |
|
Average prescribed daily dose across phase 3 Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
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Query
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moddose3 |
Float |
|
Recommended |
Modal Prescribed Dose Across P3 (mg) |
|
Modal prescribed daily dose across phase 3. Not defined for patients on Dual medication in P3 Value is stored on the first record per patient
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Query
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max1 |
Integer |
|
Recommended |
Flag: Max # Capsules Prescribed in P1 |
0;1
|
1=Yes at one record which has the maximum value of CAPSULES in phase 1/1a
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Query
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max2 |
Integer |
|
Recommended |
Flag: Max # Capsules Prescribed in P2 |
0;1
|
1=Yes at one record which has the maximum value of CAPSULES (or Clozapine dose) in phase 2
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Query
|
max3 |
Integer |
|
Recommended |
Flag: Max Dose Prescribed in P3 |
0;1
|
1=Yes at one record which has the maximum dose in phase 3. Not defined for patients on Dual medication in P3
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Query
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madh12a |
Integer |
|
Recommended |
Num of std caps prscrbd snce vis hi |
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|
|
Query
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madh12b |
Integer |
|
Recommended |
Num of std caps prscrbd snce vis low |
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|
|
Query
|
madh13 |
Float |
|
Recommended |
For Phase 3, open- label daily dose p |
|
|
|
Query
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treat_1 |
Integer |
|
Recommended |
Treatment for Phase 1 |
1::8
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine;7= Citalopram; 8=Placebo
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|
Query
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treat2 |
Integer |
|
Recommended |
Treatment for Phase 2E/2T |
1::8
|
1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7= Citalopram; 8=Placebo
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Query
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treat_3 |
Integer |
|
Recommended |
Treatment for Phase 3 (Combined) |
1::9
|
Contains treatment assigned in Phase 3. If patient was only assigned one drug in this phase, the drug name is listed. If a patient was assigned 2 drugs in Phase 3, this variable takes the value of Dual.1=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 6=Clozapine; 7=Aripiprazole; 8=Fluphenazine; 9=Dual
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Query
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dur_1 |
Float |
|
Recommended |
Duration in Phase 1 (weeks) |
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Query
|
dur_2 |
Float |
|
Recommended |
Duration in Phase 2 (weeks) |
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|
|
Query
|
dur_3 |
Float |
|
Recommended |
Duration in Phase 3 (weeks) |
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|
|
Query
|
lowdose |
Float |
|
Recommended |
# Low Dose Caps * Treatment Dose |
|
# of low dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 2.5 mg QUET: 25 mg RISP: 0.5 mg CIT: 10 mg
|
|
Query
|
highdose |
Integer |
|
Recommended |
# High Dose Caps * Treatment Dose |
|
# of high dose capsules prescribed per day multiplied by the capsule strength of treatment OLZ: 5 mg QUET: 50 mg RISP: 1 mg CIT: 20 mg
|
|
Query
|
dose |
Float |
|
Recommended |
Prescribed Dose in Phase (mg) |
|
|
|
Query
|
first_d |
Integer |
|
Recommended |
Flag: 1st Non-Miss Prescribed Dose in Ph |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
last_d |
Integer |
|
Recommended |
Flag: Last Prescribed Dose in Phase |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
first_c |
Integer |
|
Recommended |
Flag: First Caps Prscbd in HighDose in P |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
last_c |
Integer |
|
Recommended |
Flag: Last Caps Prscbd in HighDose in Ph |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
first_v |
Integer |
|
Recommended |
Flag: First Visit in Phase |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
last_v |
Integer |
|
Recommended |
Flag: Last Visit in Phase |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
dse_adj1 |
Integer |
|
Recommended |
Patient Adjusted (Inc) Dose (#Caps): P1 |
0;1
|
1=Yes if patient increased the number of capsules in phase; missing otherwise
|
|
Query
|
dse_adj2 |
Integer |
|
Recommended |
Patient Adjusted (Inc) Dose (#Caps): P2 |
0;1
|
1=Yes if patient increased the number of capsules in phase; missing otherwise
|
|
Query
|
compl_1 |
Float |
|
Recommended |
Treatment Compliance (%) Across All Visits |
|
Compliance in Phase 1
|
|
Query
|
compl_1c |
Integer |
|
Recommended |
Treatment Compliance (Categorized) Across |
1;2;3
|
1 = < 76%; 2 = 76-100%; 3 = > 100%
|
|
Query
|
compl_2 |
Float |
|
Recommended |
Treatment Compliance (%) Across All Visits |
|
Compliance in Phase 2
|
|
Query
|
compl_2c |
Integer |
|
Recommended |
Treatment Compliance (Categorized) Across |
1;2;3
|
1 = < 76%; 2 = 76-100%; 3 = > 100%
|
|
Query
|
compl_3 |
Float |
|
Recommended |
Treatment Compliance (%) Across All Visits |
|
Compliance in Phase 3
|
|
Query
|
compl_3c |
Integer |
|
Recommended |
Treatment Compliance (Categorized) Across |
|
1 = < 76%; 2 = 76-100%; 3 = > 100%
|
|
Query
|
b1_day |
Integer |
|
Recommended |
Baseline Day - Phase 1/1A |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
b2_day |
Integer |
|
Recommended |
Baseline Day - Phase 2 |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
b3_day |
Integer |
|
Recommended |
Baseline Day - Phase 3 |
|
Number of days from study baseline to first day of the phase Based on visit dates
|
|
Query
|
boc_day |
Integer |
|
Recommended |
Baseline Visit Day- Open Choice Phase |
|
Number of days from study baseline to start date of phase
|
|
Query
|
e1_day |
Integer |
|
Recommended |
Day Discontinued from Phase 1/1A |
|
Number of days from study baseline to date of phase discontinuation Based on visit dates
|
|
Query
|
e2_day |
Integer |
|
Recommended |
Day Discontinued from Phase 2 |
|
Number of days from study baseline to date of phase discontinuation Based on visit dates
|
|
Query
|
e3_day |
Integer |
|
Recommended |
Day Discontinued from Phase 3 |
|
Number of days from study baseline to date of phase discontinuation Based on visit dates
|
|
Query
|
eoc_day |
Integer |
|
Recommended |
Visit Day Discontinued from Open Choice |
|
Number of days from study baseline to end date of phase
|
|
Query
|
es_day |
Integer |
|
Recommended |
Day Discontinued from Study |
|
Number of days from study baseline to date of study discontinuation (excluding follow-up phase) Based on visit dates
|
|
Query
|
b3_cgic |
Integer |
|
Recommended |
Phase 3 Baseline CGIC |
|
|
|
Query
|
b3_resp |
Integer |
|
Recommended |
Phase 3 Baseline CGIC Response |
|
|
|