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 1MildFlatulenceUrgency +/- <strong>in</strong>cont<strong>in</strong>enceHematochezia (rectalbleed<strong>in</strong>g)Endoscopic colorectalmucosal abnormalityTenesmusSymptoms caus<strong>in</strong>g noor m<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesSymptoms caus<strong>in</strong>g noor m<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesMild-<strong>in</strong>termittentwithout transfusionM<strong>in</strong>imal smallsuperficialdisruptions of themucosaSymptoms caus<strong>in</strong>g noor m<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesGRADE 2ModerateSymptoms caus<strong>in</strong>ggreater thanm<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesSymptoms caus<strong>in</strong>ggreater thanm<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesPersistent withouttransfusionModeratesuperficial and/orscattered deepdisruption(s) of themucosaSymptoms caus<strong>in</strong>ggreater thanm<strong>in</strong>imal<strong>in</strong>terference withusual social &functional activitiesGRADE 3SevereNASymptoms caus<strong>in</strong>g<strong>in</strong>ability to per<strong>for</strong>m usualsocial & functionalactivitiesRequir<strong>in</strong>g transfusionSevere extensive deepdisruption(s) of themucosaSymptoms caus<strong>in</strong>g<strong>in</strong>ability to per<strong>for</strong>m usualsocial & functionalactivitiesGRADE 4Potentially Lifethreaten<strong>in</strong>gNANALife-threaten<strong>in</strong>gconsequencesNANA
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