Addendum 3 Rectal Grading Table for Use in Microbicide Studies ...
Addendum 3 Rectal Grading Table for Use in Microbicide Studies ...
Addendum 3 Rectal Grading Table for Use in Microbicide Studies ...
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DIVISION OF AIDS TABLE FOR GRADING THE SEVERITY OF ADULT AND PEDIATRIC ADVERSE EVENTS<strong>Addendum</strong> 3 <strong>Rectal</strong> <strong>Grad<strong>in</strong>g</strong> <strong>Table</strong> <strong>for</strong> <strong>Use</strong> <strong>in</strong> <strong>Microbicide</strong> <strong>Studies</strong>Clarification dated May 2012PARAMETER GRADE 1MildGRADE 2ModerateGRADE 3SevereFistulae, <strong>in</strong>dicate site Dry fistulae Dra<strong>in</strong><strong>in</strong>g fistulae Fistulae requir<strong>in</strong>gmedical/surgical<strong>in</strong>terventionAbdom<strong>in</strong>al Pa<strong>in</strong>STIsHSVPa<strong>in</strong> caus<strong>in</strong>g no orm<strong>in</strong>imal <strong>in</strong>terferencewith usual social & orfunctional activitiesPresent but notreatment requiredPa<strong>in</strong> caus<strong>in</strong>g greaterthan m<strong>in</strong>imal<strong>in</strong>terference withusual social & orfunctional activitiesTreatment requiredPa<strong>in</strong> caus<strong>in</strong>g <strong>in</strong>ability toper<strong>for</strong>m usual social & orfunctional activitiesComplicated diseaserequir<strong>in</strong>g medical/surgical <strong>in</strong>terventionChlamydia NA Treatment required Complicated diseaserequir<strong>in</strong>g medical/surgical <strong>in</strong>terventionSyphilis NA Treatment required Complicated diseaserequir<strong>in</strong>g medical/surgical <strong>in</strong>terventionGonorrhea NA Treatment required Complicated diseaserequir<strong>in</strong>g medical/surgical <strong>in</strong>terventionLymphogranulomavenereumNA Treatment required Complicated diseaserequir<strong>in</strong>g medical/surgical <strong>in</strong>terventionGRADE 4Potentially Lifethreaten<strong>in</strong>gLife-threaten<strong>in</strong>gconsequencesDisabl<strong>in</strong>g pa<strong>in</strong> caus<strong>in</strong>g<strong>in</strong>ability to per<strong>for</strong>mbasic self-care ORHospitalization (otherthan emergency roomvisit) <strong>in</strong>dicatedNANANANANA
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