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SDTM 1.1/IG 3.1.1 ANNOTATION FOR CTN0028 NOTE: Boxed annotations indicate supplemental qualifier variables. Result found in QVAL field. DOMAIN: SC SCTEST SCORRES USUBJID DOMAIN: DS USUBJID DSCAT=DISPOSITION EVENT DSDECOD = SUBJECT ENROLLED DSTERM=SUBJECT ENROLLED SCCAT=DEMOGRAPHICS DOMAIN: DM, SC USUBJID SCTEST/SCORRES DMDTC VISITNUM/VISIT SEX BRTHDTC ETHNIC DM.RACE (if multiple then = ‘MULTIPLE”) SCTEST SCORRES QNAM=AOTHERS QLABEL=ASIAN OTHER TEXT IDVAR=SCSEQ SCTEST SCORRES SCORRES SCTEST QNAM=NOTHERS QLABEL=NATIVE HAWAIIAN OR PACIFIC ISLANDER OTHER TEXT IDVAR=SCSEQ DM.RACE (if multiple then = ‘MULTIPLE”) DOMAIN: DM, SC SCORRES SCTEST QNAM=OOTHERS QLABEL=ETHNICITY/RACE OTHER TEXT IDVAR=SCSEQ SCTEST SCORRES SCTEST SCORRES QSCAT=DSM-IV ADHD CHECKLIST DOMAIN: QS QSDTC VISITNUM/VISIT QSSPID QSTEST QSORRES QSCAT=K-SADS-E ADHD MODULE –INTERVIEW SUMMARY DOMAIN: QS/CO QSDTC VISITNUM/VISIT QSSCAT = INATTENTION QSTEST QSORRES CO.COVAL IDVAR=QSSEQ QSSCAT = HYPERACTIVITY/IMPULSIVITY QSTEST QSORRES CO.COVAL IDVAR=QSSEQ QSCAT=K-SADS-E ADHD MODULE –INTERVIEW SUMMARY DOMAIN: QS QSDTC VISITNUM/VISIT QSSCAT = ADDITIONAL SYMPTOMS QSTEST QSORRES CO.COVAL IDVAR=QSSEQ QSTEST QSORRES QSCAT=ASRS DOMAIN: QS QSDTC VISITNUM/VISIT QSTEST QSORRES CMCAT = ‘PRIOR AND CONCOMITANT MEDICATIONS’ DOMAIN: CM CMDTC VISITNUM/VISIT CMSEQ There is only a record in the CM dataset QNAM=TRTFORAE QLABEL=DRUG GIVEN AS TREATMENT FOR AE when the answer to this question is ‘Yes’ IDVAR=CMSEQ CMTRT QNAM=CMAEVIS CMINDC QLABEL=RELATED AE VISIT NUMBER IDVAR=CMSEQ CMDOSE QNAM=CMAEREF CMDOSU QLABEL=RELATED AE FORM SEQUENCE NUMBER IDVAR=CMSEQ CMDOSFRM CMROUTE CMDOSFRQ CMSTDTC QNAM=CMCONTV QLABEL=VISITS WHERE MED WAS ASSESSED/CONTINUED IDVAR=CMSEQ CMENDTC QNAM=VISITNO QLABEL=VISIT THAT DRUG WAS DISCONTINUED OR CHAN IDVAR=CMSEQ

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NOTE: Boxed annotations indicate supplemental qualifier variables. QSCAT=DSM-IV ADHD CHECKLIST. VISITNUM/VISIT. QSSPID. QSTEST.
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NOTE: Boxed annotations indicate supplemental qualifier variables. QSCAT=DSM-IV ADHD CHECKLIST. VISITNUM/VISIT. QSSPID. QSTEST.

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