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Description
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Notes
Data Structures with shared data
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End of Phase Form

endphase

01

Clinical Trials: End of Phase Form

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/projectCATIEID
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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.
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired field
genderString20RequiredSex of the subjectM;FM = Male; F = Female
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
visitString50RecommendedVisit nameCharacter description of each type of visit
truncvisIntegerRecommendedTruncated Visit NumberCreated variable: provides a numeric visit number for all visits, including unscheduled and end of phase
phase_ctString20RecommendedCurrent 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
visdayIntegerRecommendedNumber of days from study baseline to date of visit
protocolString50RecommendedProtocol [Study] name
rtd01IntegerRecommendedDay of phase discontinuationNumber of days from study baseline to date of phase discontinuationdayeop12, dayeop36
rtd02IntegerRecommendedDid pt successfully complete the medication0;10=No; 1=Yes, Skip to Section IV
rtd03IntegerRecommendedI.1 Administrative Discontinuation - Wer0;10=No;1= Yeseop03
rtd04IntegerRecommendedII. Clinical Discontinuation0;10=No;1= Yeseop04
rtd05aIntegerRecommendedInadequate therapeutic effect1;01=yes; 0=no
rtd05bIntegerRecommendedPlease choose1;21=Primary; 2=Secondary
rtd05cIntegerRecommendedThe problematc psychopatholgy was primarily1::41=Positive; 2=Negative; 3=Affective; 4=Other reason, specify
rtd06aIntegerRecommendedUnacceptable side effects0;10=No;1= Yes
rtd06bIntegerRecommendedPlease choose1;21=Primary; 2=Secondary
rtd06cIntegerRecommendedThe most problematic side effect was1::41=Extrapyramidal; 2=Weight/Metabolic; 3=Sexual; 4=Other reason, specify
rtd07aIntegerRecommendedRefusal/failure to take assigned antipsychotics0;10=No;1= Yes
rtd07cIntegerRecommendedIs patient agereable with taking diffrent antipsychotics?0;10=No;1= Yes
rtd08IntegerRecommendedPatient withdrawn by subject advocate0;10=No;1= Yes
rtd09IntegerRecommendedIs the pt proceeding to the next medicat0;10=No;1= Yes
rtd10IntegerRecommendedDid a substance use disorder contribute0;10=No;1= Yes
rtd11IntegerRecommendedCLINICIAN: Which medication do you think was used1::5;95;991=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
rtd12IntegerRecommendedpt: Which medication do you think you were taken1::5;95;991=Olanzapine; 2=Quetiapine; 3=Risperidone; 4=Ziprasidone; 5=Perphenazine; 95=Refused to guess; 99=N/A On open-label Clozapine
rtd13IntegerRecommendedInvestigator signed end of phase source document0;10=No;1= Yes
rtd14IntegerRecommendedInvestigator faxed end of phase source document0;10=No;1= Yes
eop01IntegerRecommendedWhat phase is the patient being discontinued from?1;2;3;41=1; 2=2; 3=3; 4=Open Choicefhx10a
eop02aIntegerRecommendedDid the patient complete the full 36 weeks of study?0;10=No; 1=Yesfhx10b
eop04aIntegerRecommendedClinical Discontinuation: If yes, please state the reason1;2;3;4;51 = a. Inadequate therapeutic effect; 2 = b. Study drug was not sufficiently optim; 3 = c. Worsening of symptoms; 4 = d. Unacceptable side effects';' 5 = e. Study drug is no longer needed
eop04bIntegerRecommendedII. Clinical Discontinuation: The most problematic side effect was:1;2;3;4;5;6;71 = Extrapyramidal; 2 = Weight gain; 3 = Weight loss; 4 = Falling; 5 = Syncope/dizziness/vertigo; 6 = Confusion; 7 = Other reason
eop05IntegerRecommendedRefusal/failure to take the assigned study drug0;10=No; 1=Yes
eop05bIntegerRecommendedPatient Decision: Is the patient agreeable with taking a different study drug?0;10=No; 1=Yes
eop06IntegerRecommendedCaregiver's decision0;10=No; 1=Yes
eop06bIntegerRecommendedCaregiver's Decision: Is the caregiver agreeable with the patient taking a different study drug?0;10=No; 1=Yes
eop07IntegerRecommendedPatient died during this study phase0;10=No; 1=Yes
eop08IntegerRecommendedWhat is the course of action for the patient?1;2;31 = Move to next randomized phase; 2 = Move to open-choice phase; 3 = Discontinued from the study*
eop08aIntegerRecommendedCourse of Action: What randomized phase proceeding to?2;32=2; 3=3
eop09IntegerRecommendedHas the investigator signed the End of Phase source document?0;10=No; 1=Yes
eop02IntegerRecommendedDay of phase discontinuationNumber of days from study baseline to date of phase discontinuation
eop10IntegerRecommendedInvestigators Signature Day signed:Number of days from study baseline to date investigator's signature was obtained
eop07aIntegerRecommendedPatient Death: Day of patient deathNumber of days from study baseline to date of death
daylast1vstIntegerRecommendedstudy day of last TREATMENT visitdaylast2vst
complet1IntegerRecommendedDid this child complete Phase TREATMENT PORTION of the study?0;10 = no; 1 = yescomplet2
y1notdunIntegerRecommendedWhich one of the following explains why the subject did not complete Phase1::41 = Study dropout; 2 = Treatment dropout; 3 = Premature termination; 4 = Other reasony2notdun, y2notdun_d
lastp1wkIntegerRecommendedWeek of last TREATMENT visitlastp2wk
camsresponseIntegerRecommendedTREATMENT RESPONSE from End of Phase Form1;2;3;41 = Active Treatment Responder;2 = Active Treatment Non-responder;3 = Placebo Responder;4 = Placebo Non-responder
actvrespIntegerRecommendedActive Treatment responder: Does family agree to continue in maintenance treatment?0;10 = no; 1 = yes
nomaintxString50RecommendedActive Treatment responder: Explain no maintenance treatment
actvnonrIntegerRecommendedActive Treatment non-responder: Does family agree to community referral?0;10 = no; 1 = yes
nocomrefString50RecommendedActive Treatment non-responder: Explain no community referral
pborespIntegerRecommendedPlacebo responder: Does family agrees to monthly maintenance visits and IE assessments?0;10 = no; 1 = yes
nostoptxString50RecommendedPlacebo responder: Explain no maintenance and IE assessments
openlablIntegerRecommendedPlacebo non-responder: Does family agree to Open-label CAMS Treatment?0;10 = no; 1 = yes
treatment_nameString200Recommendedtreatment name
noopnlblString50RecommendedPlacebo non-responder: Explain no Open Label
faz1doneIntegerRecommendedDid child complete Phase Assessments?0;10 = no; 1 = yesfaz2done
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostwk4
wkasscompIntegerRecommendedStudy Week Assessment Completed
faz2asmtIntegerRecommendedDoes the family agree to continue with Phase II Assessments?0;10 = no; 1 = yes
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form dataynofaz2
discontinuation_reason1String250RecommendedDiscontinuation Reason:otheresn
otheresn_dIntegerRecommendedOther Reason Derived1::51::5
final_r_pdIntegerRecommendedRemission Psychotic Depression: Remission was defined as a HAM-D 17 item score of 10 or lower at 2 consecutive assessments. Remission also required the absence of delusions (SADS delusional item score of 1) at the second remission of depression assessment. Subjects who were not delusional at both of 2 consecutive HAM-D assessments were considered remitted at both points; subjects who had been delusional at the first of the HAM-D assessments were considered to be remitted at the second assessment only, and subjects who were not delusional at the first assessment but had SADS scores higher than 1 at the second were classified as not remitted at either assessment. Subjects who achieved a HAM-D score of 10 or lower without delusions for the first time at week 12 were assessed again at week 13 to determine whether the 2-week duration criterion was met.0;10 = no; 1 = yes
lastvisitIntegerRecommendedThis variable indicates whether the assessment was the last for the subject. For the acute phase, this is generally at week 12, but the last weekly visit will vary for early terminators.0;10 = no; 1 = yes
outcome_textString100RecommendedOutcome Text
outcome_idIntegerRecommendedOutcome Code2::422 = Dropped Medical Reasons - Side Effects; 3 = Dropped Medical Reasons - Inter-current Events; 7 = No Longer Meets Study Criteria; 14 = Completed Study; 20 = Other; 21 = Death - non-suicide; 22 = Suicide attempt or increased suicidality; 23 = Worsening depression; 24 = Lost to follow-up; 25 = Patient moved - distance; 26 = Worsening psychosis; 27 = Worsening depression and psychosis; 28 = Other emergent psychiatric symptoms; 29 = Patient Perception: Clinical improvement; 30 = Completed suicide attempt; 34 = Patient perception: Ineffective treatment; 35 = Patient changed mind about participation in research; 36 = Patient's family opposed to his/her study participation; 37 = Patient refused further study med treatment (not due to side effects); 38 = Problems with transportation; 39 = Protocol violation; 41 = Inappropriate for research participation; 42 = Insufficient therapeutic response
outcomedaysIntegerRecommendedOutcome Days from Baseline
statusaIntegerRecommendedWhat was the outcome of the Acute Phase?1::31 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Non-remitted; 4 = Randomized then exited
stabyesnoIntegerRecommendedFor Partial and Full Remitters at 12 weeks: Will patient enter Stabilization Phase?0;10 = no; 1 = yes
nostabexplainString500RecommendedExplain not going into Stabilization
study_idIntegerRecommendedStudy ID number46=Acute Phase; 47=Stabilization Phase
inttimewkIntegerRecommendedWeek of study: Initial-2 = pre-baseline (2 weeks); -1 = pre-baseline (1 week); 0 = baseline; 1 = week 1; 12 = week 12; 13 = week 13; 14 = week 14
weekFloatRecommendedWeek in level/study99=week 10-week 14intid
siteString100RecommendedSiteStudy Site
statussIntegerRecommendedWhat was the outcome of the Stabilization Phase?1::41 = Met Full Remission criteria; 2 = Met Partial Remission criteria; 3 = Relapse; 4 = Significant Clinical Worsening
responsibleIntegerRecommendedIf outcome is Early Termination, who was the primary person responsible for the early termination?1::51 = Patient; 2 = Study Investigator; 3 = Physician at institution- not involved in study; 4 = Physician outside institution (e.g., Primary care physician); 5 = Family member or significant other
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
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Distribution for DataStructure: endphase01 and Element:
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