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IG33_OE_AE_004 IG33_OE_DI_003 IG33_OE_OE_001 IG33_OE_OE_002 IG33_OE_OE_003 IG33_OE_OE_004 IG33_OE_PR_003 IG33_OE_RELREC_003 IG33_OE_SUPPOE_001 IG33_OE_SUPPOE_002 IG33_OE_SUPPOE_003 IG33_OE_SUPPOE_004 IG33_OE_SUPPPR_003
Example STUDYID DOMAIN USUBJID FOCID AESEQ AESPID AETERM AEDECOD AEBODSYS AELOC AELAT AESEV AESER AEACN AEREL AEOUT AESTDTC AEENDTC
IG33_OE_AE_004 XYZ AE XYZ-100-0001 5 1 Headaches Headache Nervous system disorders MILD N DOSE NOT CHANGED NOT RELATED RECOVERED/RESOLVED 2011-05-02 2011-05-06
IG33_OE_AE_004 XYZ AE XYZ-100-0001 OD 6 2 Worsening Dry Eyes Dry eye Eye disorders EYE RIGHT MODERATE N DOSE NOT CHANGED NOT RELATED RECOVERED/RESOLVED 2011-05-03 2011-05-05
IG33_OE_AE_004 XYZ AE XYZ-100-0001 OS 7 2 Worsening Dry Eyes Dry eye Eye disorders EYE LEFT MODERATE N DOSE NOT CHANGED NOT RELATED RECOVERED/RESOLVED 2011-05-03 2011-05-04
Example STUDYID DOMAIN SPDEVID DISEQ DIPARMCD DIPARM DIVAL
IG33_OE_DI_003 XYZ DI 100 1 TYPE Device Type OCT
IG33_OE_DI_003 XYZ DI 100 2 MANUF Manufacturer ZEISS
IG33_OE_DI_003 XYZ DI 100 3 MODEL Model CIRRUS
IG33_OE_DI_003 XYZ DI 100 4 SERIAL Serial Number yyyyyy
Example STUDYID DOMAIN USUBJID FOCID OESEQ OETESTCD OETEST OEORRES OESTRESC OELOC OELAT OEDIR OEMETHOD OEEVAL VISITNUM VISIT OEDTC
IG33_OE_OE_001 XXX OE XXX-450-110 OS 1 INTP Interpretation NORMAL NORMAL LENS LEFT SLIT LAMP INVESTIGATOR 1 SCREENING 2012-03-20
IG33_OE_OE_001 XXX OE XXX-450-110 OD 2 INTP Interpretation ABNORMAL ABNORMAL LENS RIGHT SLIT LAMP INVESTIGATOR 1 SCREENING 2012-03-20
IG33_OE_OE_001 XXX OE XXX-450-110 OD 3 OEEXAM Ophthalmic Examination RED SPOT VISIBLE RED SPOT VISIBLE CONJUNCTIVA RIGHT MULTIPLE SLIT LAMP INVESTIGATOR 1 SCREENING 2012-03-20
Example STUDYID DOMAIN USUBJID FOCID OESEQ OETESTCD OETEST OEORRES OEORRESU OESTRESC OESTRESN OESTRESU OELOC OELAT OEMETHOD OEEVAL VISITNUM VISIT OEDTC
IG33_OE_OE_002 XXX OE XXX- 450-120 OD 1 COLOR Color BLUE BLUE IRIS RIGHT SLIT LAMP BIOMICROSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OS 2 COLOR Color BLUE BLUE IRIS LEFT SLIT LAMP BIOMICROSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OD 3 LENSSTAT Lens Status PHAKIC PHAKIC LENS RIGHT SLIT LAMP BIOMICROSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OS 4 LENSSTAT Lens Status PSEUDOPHAKIC PSEUDOPHAKIC LENS LEFT SLIT LAMP BIOMICROSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OD 5 HYPERMIA Hyperemia PRESENT PRESENT CONJUNCTIVA RIGHT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OS 6 HYPERMIA Hyperemia ABSENT ABSENT CONJUNCTIVA LEFT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OD 7 CUPDISC Cup-to-Disc Ratio 0.5 RATIO 0.5 0.5 RATIO OPTIC DISC RIGHT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
IG33_OE_OE_002 XXX OE XXX- 450-120 OS 8 CUPDISC Cup-to-Disc Ratio 0.6 RATIO 0.6 0.6 RATIO OPTIC DISC LEFT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-20
Example STUDYID DOMAIN USUBJID FOCID OESEQ OELNKID OETESTCD OETEST OEORRES OEORRESU OESTRESC OESTRESN OESTRESU OELOC OELAT OEMETHOD OEEVAL VISITNUM VISIT OEDTC
IG33_OE_OE_003 XYZ OE XYZ-100-001 OS 1 EDEMA Edema PRESENT PRESENT MACULA LEFT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-25
IG33_OE_OE_003 XYZ OE XYZ- 100-001 OD 2 EDEMA Edema ABSENT ABSENT MACULA RIGHT OPHTHALMOSCOPY INVESTIGATOR 1 SCREENING 2012-04-25
IG33_OE_OE_003 XYZ OE XYZ- 100-001 OS 3 1 EDEMA Edema PRESENT PRESENT MACULA LEFT OPTICAL COHERENCE TOMOGRAPHY INDEPENDENT ASSESSOR 1 SCREENING 2012-04-25
IG33_OE_OE_003 XYZ OE XYZ- 100-001 OD 4 2 EDEMA Edema ABSENT ABSENT MACULA RIGHT OPTICAL COHERENCE TOMOGRAPHY INDEPENDENT ASSESSOR 1 SCREENING 2012-04-25
IG33_OE_OE_003 XYZ OE XYZ- 100-001 OS 5 1 THICK Thickness 1030 um 1030 1030 um MACULA LEFT OPTICAL COHERENCE TOMOGRAPHY INDEPENDENT ASSESSOR 1 SCREENING 2012-04-25
IG33_OE_OE_003 XYZ OE XYZ- 100-001 OD 6 2 THICK Thickness 1005 um 1005 1005 um MACULA RIGHT OPTICAL COHERENCE TOMOGRAPHY INDEPENDENT ASSESSOR 1 SCREENING 2012-04-25
Example STUDYID DOMAIN USUBJID FOCID OESEQ OETESTCD OETEST OECAT OEORRES OESTRESC OESTRESN OELOC OELAT OEMETHOD OEEVAL VISITNUM VISIT OEDTC OETPT OETPTNUM
IG33_OE_OE_004 XYZ OE XYZ-100-0001 OD 1 DRPCMTGR Drop Comfort Grade OCCULAR COMFORT 1 1 1 EYE RIGHT VISUAL ANALOG SCALE STUDY SUBJECT 1 VISIT 1 2011-02-11T09:00 UPON INSTILLATION 1
IG33_OE_OE_004 XYZ OE XYZ-100-0001 OD 2 DRPCMTGR Drop Comfort Grade OCCULAR COMFORT 10 10 10 EYE RIGHT VISUAL ANALOG SCALE STUDY SUBJECT 1 VISIT 1 2011-02-11T09:01 1 MINUTE POST-INSTILLATION 2
IG33_OE_OE_004 XYZ OE XYZ-100-0001 OS 1 DRPCMTGR Drop Comfort Grade OCCULAR COMFORT 1 1 1 EYE LEFT VISUAL ANALOG SCALE STUDY SUBJECT 1 VISIT 1 2011-05-01T09:00 UPON INSTILLATION 1
IG33_OE_OE_004 XYZ OE XYZ-100-0001 OS 2 DRPCMTGR Drop Comfort Grade OCCULAR COMFORT 10 10 10 EYE LEFT VISUAL ANALOG SCALE STUDY SUBJECT 1 VISIT 1 2011-05-01T09:01 1 MINUTE POST-INSTILLATION 2
Example STUDYID DOMAIN USUBJID FOCID SPDEVID PRSEQ PRLNKID PRTRT PRPRESP PROCCUR PRLOC PRLAT PRSTDTC VISITNUM VISIT
IG33_OE_PR_003 XYZ PR XYZ- 100-001 OS 100 1 1 OCT Y Y EYE LEFT 2012-04-25T09:30:00 1 SCREENING
IG33_OE_PR_003 XYZ PR XYZ- 100-001 OD 100 2 2 OCT Y Y EYE RIGHT 2012-04-25T10:10:00 1 SCREENING
IG33_OE_PR_003 XYZ PR XYZ- 100-001 OS 100 3 3 OCT Y Y EYE LEFT 2012-05-25T08:00:00 2 VISIT 1
IG33_OE_PR_003 XYZ PR XYZ- 100-001 OD 100 4 4 OCT Y Y EYE RIGHT 2012-05-25T08:30:00 2 VISIT 1
IG33_OE_PR_003 XYZ PR XYZ- 100-001 OU 5 OCT Y N 3 VISIT 2
Example STUDYID RDOMAIN USUBJID IDVAR IDVARAL RELTYPE RELID
IG33_OE_RELREC_003 XYZ PR PRLNKID ONE 13
IG33_OE_RELREC_003 XYZ OE OELNKID MANY 13
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
IG33_OE_SUPPOE_001 XXX OE XXX- 450-110 OESEQ 3 OECLSIG Clinically Significant Y
IG33_OE_SUPPOE_001 XXX OE XXX- 450-110 OESEQ 3 OEDIR1 Directionality 1 SUPERIOR
IG33_OE_SUPPOE_001 XXX OE XXX- 450-110 OESEQ 3 OEDIR2 Directionality 2 TEMPORAL
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
IG33_OE_SUPPOE_002 XXX OE XXX- 450-120 OESEQ 5 OECLSIG Clinically Significant Y
IG33_OE_SUPPOE_002 XXX OE XXX- 450-120 OESEQ 7 TSTCND Testing Condition DILATED
IG33_OE_SUPPOE_002 XXX OE XXX- 450-120 OESEQ 8 TSTCND Testing Condition DILATED
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
IG33_OE_SUPPOE_003 XYZ OE XYZ- 100-001 OESEQ 1 OECLSIG Clinically Significant Y
IG33_OE_SUPPOE_003 XYZ OE XYZ- 100-001 OESEQ 2 OECLSIG Clinically Significant N
IG33_OE_SUPPOE_003 XYZ OE XYZ- 100-001 OELNKID 1 EVLDTC Evaluation Date 2012-04-30
IG33_OE_SUPPOE_003 XYZ OE XYZ- 100-001 OELNKID 2 EVLDTC Evaluation Date 2012-04-30
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
IG33_OE_SUPPOE_004 XYZ OE XYZ-100-0001 OECAT OCULAR COMFORT RESCRT Result Criteria 10-point VAS (1=Best, 10=Worst)
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL
IG33_OE_SUPPPR_003 XYZ PR XYZ- 100-001 PRSEQ 5 OEREASOC Reason for Occur Value Patient was sick for # weeks