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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Phase Discontinuation Variables

1,881 Shared Subjects

Clinical Trials: Phase Discontinuation Variables
Clinical Assessments
Summary
05/08/2014
timeto01
12/16/2022
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project CATIEID
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0::1440 Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query tmdisc1 Float Recommended Number of months between phase start date and end date in Phase 1/1A 1 month is defined as 28 days
Query tmdisc1b Float Recommended Number of months between phase start date and end date in Phase 1B 1 month is defined as 28 days
Query tmdisc2 Float Recommended Number of months between phase start date and end date in Phase 2 1 month is defined as 28 days
Query tmdisc3 Float Recommended Number of months between phase start date and end date in Phase 3 1 month is defined as 28 days
Query censor1 Integer Recommended Censored in Phase 1/1A 0;1 1= if patient completed both the phase and study; 0 otherwise
Query censor1b Integer Recommended Censored in Phase 1B 0;1 1= if patient completed both the phase and study; 0 otherwise
Query censor2 Integer Recommended Censored in Phase 2 0;1 1= if patient completed both the phase and study; 0 otherwise
Query trncdur1 Integer Recommended P1 patient's duration in phase was truncated to 74 days after the last patient visit 0;1 1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
Query trncdr1b Integer Recommended P1B patient's duration in phase was truncated to 74 days after the last patient visit 0;1 1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
Query trncdur2 Integer Recommended P2 patient's duration in phase was truncated to 74 days after the last patient visit 0;1 1= if patient's duration in phase was truncated to 74 days after the last patient visit (necessary for some patients who were lost to follow-up but the site recorded a phase discontinuation date longer than 74 days after last patient contact. 74 days is 2 months after the visit, including a 2-week visit window); missing otherwise
Query dcr_eff1 Integer Recommended patient discontinued phase 1/1A due to lack of efficacy 0;1 1= if patient discontinued phase 1/1A due to lack of efficacy; 0 otherwise
Query dcr_eff2 Integer Recommended patient discontinued phase 2 due to lack of efficacy 0;1 1= if patient discontinued phase 2 due to lack of efficacy; 0 otherwise
Query dcr_tae1 Integer Recommended patient discontinued phase 1/1A due to unacceptable side effects 0;1 1= if patient discontinued phase 1/1A due to unacceptable side effects; 0 otherwise
Query dcr_tae2 Integer Recommended patient discontinued phase 2 due to unacceptable side effects 0;1 1= if patient discontinued phase 2 due to unacceptable side effects; 0 otherwise
Query dcr_pat1 Integer Recommended patient discontinued phase 1/1A due to patient/subject advocate's decision 0;1 1= if patient discontinued phase 1/1A due to patient/subject advocate's decision; 0 otherwise
Query dcr_pat2 Integer Recommended patient discontinued phase 2 due to patient/subject advocate's decision 0;1 1= if patient discontinued phase 2 due to patient/subject advocate's decision; 0 otherwise
Query tmsucc1 Integer Recommended Time (months) with Successful Treatment Number of months in Phase 1/1A patient has CGIS response=1
Query compeff Integer Recommended Composite Ordinal Effectiveness Outcome 1::5 for Phase 1/1A: 1=Completed with improvement; 2=Discontinued with Improvement; 3=Completed w/o improvement; 4=Discontinued w/o Improvement; 5=Discontinued for Safety
Query dcr_pgo1 Integer Recommended P1 patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase 0;1 1= if patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase; 0 otherwise
Query dcr_pgo2 Integer Recommended P2 patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase 0;1 1= if patient discontinued phase due to patient/subject advocate's decision AND the patient went on to the next phase; 0 otherwise
Query dcr_pst1 Integer Recommended 1/1A patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study 0;1 1= if patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study; 0 otherwise
Query dcr_pst2 Integer Recommended P2 patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study 0;1 1= if patient discontinued phase due to patient/subject advocate's decision AND the patient terminated the study; 0 otherwise
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 b1b_day Integer Recommended Baseline Day - Phase 1B 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 enddy_1 Integer Recommended Number of days from study baseline to end date of phase 1/1A
Query enddy_1b Integer Recommended Number of days from study baseline to end date of phase 1B
Query enddy_2 Integer Recommended Number of days from study baseline to end date of phase 2
Query enddy_3 Integer Recommended Number of days from study baseline to end date of phase 3
Query enddy_s Integer Recommended Number of days from study baseline to end date of study
Query eov03 Integer Recommended Was the patient permanently admitted to a nursing home since the last visit? 0;1 0=No; 1=Yes
Query cva Integer Recommended Cerebrovascular Event 1; 0 1=yes,if patient had a CVA; missing otherwise; 0=no
Query tmcva Float Recommended Time (weeks) to Cerebrovascular Event Weeks from study baseline
Query tmdeath Float Recommended Time (weeks) to Death Weeks from study baseline
Query tmnhp Float Recommended Time to Nursing Home Placement Weeks from study baseline
Query deathdy Integer Recommended Day of Death Number of days from study baseline/randomization to date of death eos04d
Query fwfa1 Integer Recommended Date of study withdrawal eos01a
Query eos01b Integer Recommended Day of withdrawal: Number of days from study baseline to end of study (withdrawals only)
Query eov03a Integer Recommended If yes, Day of admission: Number of days from study baseline to date of nursing home admission
Query death Integer Recommended Serious Criteria: Death 0;1 0=No; 1= Yes
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)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

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