Examples SDTM.OE

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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