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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |